Bioequivalence Study Between Levocetirizine Oral Disintegrating Tablet (ODT) and Levocetirizine Immediate Release Tablet (IRT)

• Sponsor: GlaxoSmithKline (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03555890
• Collaborator: Zensei Pharmaceutical Co., Ltd. (Other)
• Enrollment: 72
• Location: 1
• Arms: 4
• Actual Duration (Months): 4
• Patients Per Site Per Month: 18

Study Details

Study Description

Brief Summary

This study will be an open-label, randomized 2-way cross-over study to evaluate bioequivalence study between levocetirizine ODT and levocetirizine IRT in healthy Japanese male subjects. Approximately 48 subjects will participate in this study to receive a single dose treatments of levocetirizine ODT 5 milligram (mg) or levocetirizine IRT 5 mg. In Part 1, subjects will randomized in 1:1 ratio (12 in each Period) in Period 1 and 2 to receive single dose of levocetirizine ODT 5 mg with water or single dose levocetirizine IRT 5 mg with water in fasted state. In this part, comparison of bioavailability of levocetirizine ODT and levocetirizine IRT when taken with water in the fasted state will be assessed. In Part 2, subjects will be randomized in 1:1 ratio (12 in each Period) in Period 1 and 2 to receive single dose levocetirizine ODT 5 mg without water or single dose levocetirizine IRT 5 mg with water in fasted state. In this part, comparison of bioavailability of levocetirizine ODT without water and levocetirizine IRT with water in the fasted state will be assessed. There will be at least a 5-day wash out period between the intervention periods. The duration of each subject's participation in each part will be approximately 7 weeks from screening to follow-up.

Condition or Disease	Intervention/Treatment	Phase
Rhinitis	Drug: Levocetirizine IRT 5 mg; Drug: Levocetirizine ODT 5 mg	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 72 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Intervention Model Description: This study is 2-way crossover 2 part study. In Part 1, comparison of bioavailability of levocetirizine ODT and levocetirizine IRT taken with water in the fasted state will be done and In Part 2, comparison of bioavailability of levocetirizine ODT without water and levocetirizine IRT with water in the fasted state will be done.This study is 2-way crossover 2 part study. In Part 1, comparison of bioavailability of levocetirizine ODT and levocetirizine IRT taken with water in the fasted state will be done and In Part 2, comparison of bioavailability of levocetirizine ODT without water and levocetirizine IRT with water in the fasted state will be done.
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Single Centre, Single Dose, Open-label, Randomized, 2-part, 2-way Crossover Study to Determine the Bioequivalence of Levocetirizine Oral Disintegrating Tablet Given With Water and Without Water Compared to Levocetirizine Immediate Release Tablet in Healthy Japanese Male Subjects
• Actual Study Start Date: May 18, 2018
• Actual Primary Completion Date: Sep 17, 2018
• Actual Study Completion Date: Sep 17, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Subjects of Group A: Part 1 Subjects in Group A will be randomized to receive levocetirizine IRT 5 mg with 150 mL water in fasted state in Period 1. After a washout period of at least 5 days, subjects will receive levocetirizine ODT 5 mg with 150 mL water in fasted state in Period 2.	Drug: Levocetirizine IRT 5 mg; Levocetirizine IRT will be available as film-coated tablets. Subjects will receive a single dose of 5 mg levocetirizine IRT. Subjects will receive levocetirizine IRT with 150 mL water in both Part (1 and 2).; Drug: Levocetirizine ODT 5 mg; Levocetirizine ODT will be available as oral disintegrating tablet. Subjects will receive a single dose of 5 mg levocetirizine ODT. In Part 1, subjects will receive levocetirizine ODT with 150 mL water and in Part 2 subjects will receive levocetirizine ODT without water.
Experimental: Subjects of Group B: Part 1 Subjects in Group B will be randomized to receive levocetirizine ODT 5 mg with 150 mL water in fasted state in Period 1. After a washout period of at least 5 days, subjects will receive levocetirizine IRT 5 mg with 150 mL water in fasted state in Period 2.	Drug: Levocetirizine IRT 5 mg; Levocetirizine IRT will be available as film-coated tablets. Subjects will receive a single dose of 5 mg levocetirizine IRT. Subjects will receive levocetirizine IRT with 150 mL water in both Part (1 and 2).; Drug: Levocetirizine ODT 5 mg; Levocetirizine ODT will be available as oral disintegrating tablet. Subjects will receive a single dose of 5 mg levocetirizine ODT. In Part 1, subjects will receive levocetirizine ODT with 150 mL water and in Part 2 subjects will receive levocetirizine ODT without water.
Experimental: Subjects of Group C: Part 2 Subjects in Group C will be randomized to receive levocetirizine IRT 5 mg with 150 mL water in fasted state in Period 1. After a washout period of at least 5 days, subjects will receive levocetirizine ODT 5 mg without water in fasted state in Period 2.	Drug: Levocetirizine IRT 5 mg; Levocetirizine IRT will be available as film-coated tablets. Subjects will receive a single dose of 5 mg levocetirizine IRT. Subjects will receive levocetirizine IRT with 150 mL water in both Part (1 and 2).; Drug: Levocetirizine ODT 5 mg; Levocetirizine ODT will be available as oral disintegrating tablet. Subjects will receive a single dose of 5 mg levocetirizine ODT. In Part 1, subjects will receive levocetirizine ODT with 150 mL water and in Part 2 subjects will receive levocetirizine ODT without water.
Experimental: Subjects of Group D: Part 2 Subjects in Group D will be randomized to receive levocetirizine ODT 5 mg without water in fasted state in Period 1. After a washout period of at least 5 days, subjects will receive levocetirizine IRT 5 mg with 150 mL water in fasted state in Period 2.	Drug: Levocetirizine IRT 5 mg; Levocetirizine IRT will be available as film-coated tablets. Subjects will receive a single dose of 5 mg levocetirizine IRT. Subjects will receive levocetirizine IRT with 150 mL water in both Part (1 and 2).; Drug: Levocetirizine ODT 5 mg; Levocetirizine ODT will be available as oral disintegrating tablet. Subjects will receive a single dose of 5 mg levocetirizine ODT. In Part 1, subjects will receive levocetirizine ODT with 150 mL water and in Part 2 subjects will receive levocetirizine ODT without water.

Outcome Measures

Primary Outcome Measures

1. Part 1: Area Under the Concentration-time Curve (AUC) From Time Zero Time (Pre-dose) to the Time of Last Quantifiable Concentration (AUC[0-t]) of Levocetirizine [Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48 hours post-dose]

   Blood samples were collected to measure AUC(0-t) at indicated time-points. AUC(0-t) was calculated by the linear trapezoidal method (i.e., Linear Trapezoidal Linear Interpolation calculation method in Phoenix WinNonlin).

2. Part 2: AUC(0-t) of Levocetirizine [Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48 hours post-dose]

   Blood samples were collected to measure AUC(0-t) at indicated time-points. AUC(0-t) was calculated by the linear trapezoidal method (i.e., Linear Trapezoidal Linear Interpolation calculation method in Phoenix WinNonlin).

3. Part 1: Maximum Observed Concentration (Cmax) of Levocetirizine [Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48 hours post-dose]

   Blood samples were collected at indicated time points for analysis of Cmax. The values for Cmax were obtained directly from the concentration-time data.

4. Part 2: Cmax of Levocetirizine [Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48 hours post-dose]

   Blood samples were collected at indicated time points for analysis of Cmax. The values for Cmax were obtained directly from the concentration-time data.

Secondary Outcome Measures

1. Part 1: Area Under the Concentration-time Curve From Zero Time (Pre-dose) Extrapolated to Infinite Time AUC(0-inf) of Levocetirizine [Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36 and 48 hours post-dose]

   Blood samples were collected at indicated time points for analysis of AUC(0-inf). AUC(0-inf)) of levocetirizine was calculated by standard non-compartmental analysis using the currently supported version of WinNonlin (version 6.3 or higher).

2. Part 2: AUC(0-inf) of Levocetirizine [Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36 and 48 hours post-dose]

   Blood samples were collected at indicated time points for analysis of AUC(0-inf). AUC(0-inf) of levocetirizine was calculated by standard non-compartmental analysis using the currently supported version of WinNonlin (version 6.3 or higher).

3. Part 1: Time to First Occurrence of Cmax (Tmax) of Levocetirizine [Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36 and 48 hours post-dose]

   Blood samples were collected at indicated time points for analysis of tmax. The tmax of levocetirizine was obtained directly from the concentration-time data. The tmax was analyzed with the non-parametric Wilcoxon Matched Pairs Method (Signed Rank Method) to compute point estimate and associated 90% confidence interval for the median difference.

4. Part 2: Tmax of Levocetirizine [Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36 and 48 hours post-dose]

   Blood samples were collected at indicated time points for analysis of tmax. The tmax of levocetirizine was obtained directly from the concentration-time data. The tmax was analyzed with the non-parametric Wilcoxon Matched Pairs Method (Signed Rank Method) to compute point estimate and associated 90% confidence interval for the median difference.

5. Part 1: Apparent Terminal Phase Half-life (t1/2) of Levocetirizine [Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36 and 48 hours post-dose]

   Blood samples were collected at indicated time points for analysis of t1/2. The t1/2 of levocetirizine was calculated by standard non-compartmental analysis using the currently supported version of WinNonlin (version 6.3 or higher).

6. Part 2: t1/2 of Levocetirizine [Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36 and 48 hours post-dose]

   Blood samples were collected at indicated time points for analysis of t1/2. The t1/2 of levocetirizine was calculated by standard non-compartmental analysis using the currently supported version of WinNonlin (version 6.3 or higher).

7. Part 1: Percentage of AUC(0-inf) Obtained by Extrapolation (%AUCex) of Levocetirizine [Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36 and 48 hours post-dose]

   Blood samples were collected at indicated time points for analysis of %AUCex. Percentage AUCex of levocetirizine was calculated by standard non-compartmental analysis using the currently supported version of WinNonlin (version 6.3 or higher).

8. Part 2: %AUCex of Levocetirizine [Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36 and 48 hours post-dose]

   Blood samples were collected at indicated time points for analysis of %AUCex. Percentage AUCex of levocetirizine was calculated by standard non-compartmental analysis using the currently supported version of WinNonlin (version 6.3 or higher).

9. Part 1: Apparent Clearance Following Oral Dosing (CL/F) of Levocetirizine [Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36 and 48 hours post-dose]

   Blood samples were collected at indicated time points for analysis of CL/F. CL/F of levocetirizine was calculated by standard non-compartmental analysis using the currently supported version of WinNonlin (version 6.3 or higher).

10. Part 2: CL/F of Levocetirizine [Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36 and 48 hours post-dose]

    Blood samples were collected at indicated time points for analysis of CL/F. CL/F of levocetirizine was calculated by standard non-compartmental analysis using the currently supported version of WinNonlin (version 6.3 or higher).

11. Part 1: Apparent Volume of Distribution Following Oral Dosing (Vz/F) of Levocetirizine [Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36 and 48 hours post-dose]

    Blood samples were collected at indicated time points for analysis of Vz/F. Vz/F of levocetirizine was calculated by standard non-compartmental analysis using the currently supported version of WinNonlin (version 6.3 or higher).

12. Part 2: Vz/F of Levocetirizine [Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36 and 48 hours post-dose]

    Blood samples were collected at indicated time points for analysis of Vz/F. Vz/F of levocetirizine was calculated as by standard non-compartmental analysis using the currently supported version of WinNonlin (version 6.3 or higher).

13. Part 1: Elimination Rate Constant (Kel) (lambda_z) of Levocetirizine [Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36 and 48 hours post-dose]

    Blood samples were collected at indicated time points for analysis of kel. kel (lambda_z) is the first order rate constant associated with the terminal (log-linear) portion of the curve. kel of levocetirizine was calculated by standard non-compartmental analysis using the currently supported version of WinNonlin (version 6.3 or higher).

14. Part 2: Kel (lambda_z) of Levocetirizine [Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36 and 48 hours post-dose]

    Blood samples were collected at indicated time points for analysis of kel. kel (lambda_z) is the first order rate constant associated with the terminal (log-linear) portion of the curve. kel of levocetirizine was calculated by standard non-compartmental analysis using the currently supported version of WinNonlin (version 6.3 or higher).

15. Part 1: Mean Residence Time (MRT) of Levocetirizine [Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36 and 48 hours post-dose]

    Blood samples were collected at indicated time points for analysis of MRT. MRT of levocetirizine was calculated by standard non-compartmental analysis using the currently supported version of WinNonlin (version 6.3 or higher).

16. Part 2: MRT of Levocetirizine [Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36 and 48 hours post-dose]

    Blood samples were collected at indicated time points for analysis of MRT. MRT of levocetirizine was calculated by standard non-compartmental analysis using the currently supported version of WinNonlin (version 6.3 or higher).

17. Part 1: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [Up to 18 days]

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. A SAE is defined as any untoward medical occurrence that, at any dose may results in death or is life-threatening or requires inpatient hospitalization or results in persistent disability/incapacity or is a congenital anomaly/birth defect or any other situation according to medical or scientific judgment.

18. Part 2: Number of Participants With AEs and SAEs [Up to 18 days]

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. A SAE is defined as any untoward medical occurrence that, at any dose may results in death or is life-threatening or requires inpatient hospitalization or results in persistent disability/incapacity or is a congenital anomaly/birth defect or any other situation according to medical or scientific judgment.

19. Part 1: Change From Baseline in Albumin and Total Protein Levels [Baseline (Day 1, Pre-dose) and 48 hours post-dose]

    Blood samples were collected for the assessment of clinical chemistry parameters. Change from Baseline in albumin and total protein levels were evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.

20. Part 2: Change From Baseline in Albumin and Total Protein Levels [Baseline (Day 1, Pre-dose) and 48 hours post-dose]

    Blood samples were collected for the assessment of clinical chemistry parameters. Change from Baseline in albumin and total protein levels were evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.

21. Part 1: Change From Baseline in Alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatine Kinase, Gamma Glutamyl Transferase and Lactate Dehydrogenase Levels [Baseline (Day 1, Pre-dose) and 48 hours post-dose]

    Blood samples were collected for the assessment of clinical chemistry parameters. Change from Baseline in alkaline phosphatase, alanine amino transferase, aspartate amino transferase, creatine kinase, gamma glutamyl transferase and lactate dehydrogenase levels were evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.

22. Part 2: Change From Baseline in Alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatine Kinase, Gamma Glutamyl Transferase and Lactate Dehydrogenase Levels [Baseline (Day 1, Pre-dose) and 48 hours post-dose]

    Blood samples were collected for the assessment of clinical chemistry parameters. Change from Baseline in alkaline phosphatase, alanine amino transferase, aspartate amino transferase, creatine kinase, gamma glutamyl transferase and lactate dehydrogenase levels were evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.

23. Part 1: Change From Baseline in Amylase Levels [Baseline (Day 1, Pre-dose) and 48 hours post-dose]

    Blood samples were collected for the assessment of clinical chemistry parameters. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.

24. Part 2: Change From Baseline in Amylase Levels [Baseline (Day 1, Pre-dose) and 48 hours post-dose]

    Blood samples were collected for the assessment of clinical chemistry parameters. Change from Baseline in amylase levels were evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.

25. Part 1: Change From Baseline in Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid Levels [Baseline (Day 1, Pre-dose) and 48 hours post-dose]

    Blood samples were collected for the assessment of clinical chemistry parameters. Change from Baseline in direct bilirubin, total bilirubin, creatinine and uric acid levels were evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.

26. Part 2: Change From Baseline in Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid Levels [Baseline (Day 1, Pre-dose) and 48 hours post-dose]

    Blood samples were collected for the assessment of clinical chemistry parameters. Change from Baseline in direct bilirubin, total bilirubin, creatinine and uric acid levels were evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.

27. Part 1: Change From Baseline in Calcium, Cholesterol, Chloride, Glucose, High Density Lipids Cholesterol, Potassium, Low Density Lipids Cholesterol, Sodium, Phosphorus Inorganic, Triglycerides and Urea/Blood Urea Nitrogen (BUN) Levels [Baseline (Day 1, Pre-dose) and 48 hours post-dose]

    Blood samples were collected for the assessment of clinical chemistry parameters. Change from Baseline in calcium, cholesterol, chloride, glucose, high density lipids cholesterol, potassium, low density lipids cholesterol, sodium, phosphorus inorganic, triglycerides and urea/blood urea nitrogen (BUN) levels were evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.

28. Part 2: Change From Baseline in Calcium, Cholesterol, Chloride, Glucose, High Density Lipids Cholesterol, Potassium, Low Density Lipids Cholesterol, Sodium, Phosphorus Inorganic, Triglycerides and Urea/BUN Levels [Baseline (Day 1, Pre-dose) and 48 hours post-dose]

    Blood samples were collected for the assessment of clinical chemistry parameters. Change from Baseline in calcium, cholesterol, chloride, glucose, high density lipids cholesterol, potassium, low density lipids cholesterol, sodium, phosphorus inorganic, triglycerides and urea/BUN levels were evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.

29. Part 1: Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes and Total Neutrophils Count [Baseline (Day 1, Pre-dose) and 48 hours post-dose]

    Blood samples were collected for the assessment of hematology parameters. Change from Baseline in basophils, eosinophils, lymphocytes, monocytes and total neutrophils levels were evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.

30. Part 2: Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes and Total Neutrophils Count [Baseline (Day 1, Pre-dose) and 48 hours post-dose]

    Blood samples were collected for the assessment of hematology parameters. Change from Baseline in basophils, eosinophils, lymphocytes, monocytes and total neutrophils levels were evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.

31. Part 1: Change From Baseline in Platelet Count and White Blood Cell Count [Baseline (Day 1, Pre-dose) and 48 hours post-dose]

    Blood samples were collected for the assessment of hematology parameters. Change from Baseline in platelet count and white blood cell count were evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.

32. Part 2: Change From Baseline in Platelet Count and White Blood Cell Count [Baseline (Day 1, Pre-dose) and 48 hours post-dose]

    Blood samples were collected for the assessment of hematology parameters. Change from Baseline in platelet count and white blood cell count were evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.

33. Part 1: Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration [Baseline (Day 1, Pre-dose) and 48 hours post-dose]

    Blood samples were collected for the assessment of hematology parameters. Change from Baseline in hemoglobin and mean corpuscle hemoglobin concentration were evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.

34. Part 2: Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration [Baseline (Day 1, Pre-dose) and 48 hours post-dose]

    Blood samples were collected for the assessment of hematology parameters. Change from Baseline in hemoglobin and mean corpuscle hemoglobin concentration were evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.

35. Part 1: Change Form Baseline in Hematocrit [Baseline (Day 1, Pre-dose) and 48 hours post-dose]

    Blood samples were collected for the assessment of hematology parameters. Change from Baseline in hematocrit was evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.

36. Part 2: Change Form Baseline in Hematocrit [Baseline (Day 1, Pre-dose) and 48 hours post-dose]

    Blood samples were collected for the assessment of hematology parameters. Change from Baseline in hematocrit was evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.

37. Part 1: Change From Baseline in Mean Corpuscle Hemoglobin [Baseline (Day 1, Pre-dose) and 48 hours post-dose]

    Blood samples were collected for the assessment of hematology parameters. Change from Baseline in mean corpuscle hemoglobin was evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.

38. Part 2: Change From Baseline in Mean Corpuscle Hemoglobin [Baseline (Day 1, Pre-dose) and 48 hours post-dose]

    Blood samples were collected for the assessment of hematology parameters. Change from Baseline in mean corpuscle hemoglobin was evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.

39. Part 1: Change From Baseline in Mean Corpuscle Volume [Baseline (Day 1, Pre-dose) and 48 hours post-dose]

    Blood samples were collected for the assessment of hematology parameters. Change from Baseline in mean corpuscle volume was evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.

40. Part 2: Change From Baseline in Mean Corpuscle Volume [Baseline (Day 1, Pre-dose) and 48 hours post-dose]

    Blood samples were collected for the assessment of hematology parameters. Change from Baseline in mean corpuscle volume was evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.

41. Part 1: Change From Baseline in Red Blood Cell Count [Baseline (Day 1, Pre-dose) and 48 hours post-dose]

    Blood samples were collected for the assessment of hematology parameters. Change from Baseline in red blood cell count was evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.

42. Part 2: Change From Baseline in Red Blood Cell Count [Baseline (Day 1, Pre-dose) and 48 hours post-dose]

    Blood samples were collected for the assessment of hematology parameters. Change from Baseline in red blood cell count was evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.

43. Part 1: Change From Baseline in Reticulocytes [Baseline (Day 1, Pre-dose) and 48 hours post-dose]

    Blood samples were collected for the assessment of hematology parameters. Change from Baseline in reticulocytes was evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.

44. Part 2: Change From Baseline in Reticulocytes [Baseline (Day 1, Pre-dose) and 48 hours post-dose]

    Blood samples were collected for the assessment of hematology parameters. Change from Baseline in reticulocytes was evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.

45. Part 1: Number of Participants With Urinalysis Results by Dipstick Method [Pre-dose (Day 1) and 48 hours post-dose]

    Urine samples were collected to assess urine bilirubin, urine occult blood, urine glucose, urine ketones, urine protein and urine urobilinogen by dipstick test. The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameter of urine bilirubin, urine occult blood, urine glucose, urine ketones, urine protein and urine urobilinogen can be read as negative (-), trace and 1+ indicating proportional concentrations in the urine sample. Only categories with significant values have been presented.

46. Part 2: Number of Participants With Urinalysis Results by Dipstick Method [Pre-dose (Day 1) and 48 hours post-dose]

    Urine samples were collected to assess urine bilirubin, urine occult blood, urine glucose, urine ketones, urine protein and urine urobilinogen by dipstick test. The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameter of urine bilirubin, urine occult blood, urine glucose, urine ketones, urine protein and urine urobilinogen can be read as negative (-), trace and 1+ indicating proportional concentrations in the urine sample. Only categories with significant values have been presented.

47. Part 1: Urine Potential of Hydrogen (pH) [Pre-dose (Day 1) and 48 hours post-dose]

    Urine samples were collected for the measurement of urine pH. Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acid pH (5.0 - 6.0).

48. Part 2: Urine Potential of Hydrogen (pH) [Pre-dose (Day 1) and 48 hours post-dose]

    Urine samples were collected for the measurement of urine pH. Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acid pH (5.0 - 6.0).

49. Part 1: Urine Specific Gravity [Pre-dose (Day 1) and 48 hours post-dose]

    Urine samples were collected for the measurement of specific gravity. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. The concentration of the excreted molecules determines the urine's specific gravity. The urinary specific gravity measurement is a routine part of urinalysis. The reference range is 1.002-1.030.

50. Part 2: Urine Specific Gravity [Pre-dose (Day 1) and 48 hours post-dose]

    Urine samples were collected for the measurement of specific gravity. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. The concentration of the excreted molecules determines the urine's specific gravity. The urinary specific gravity measurement is a routine part of urinalysis. The reference range is 1.002-1.030.

51. Part 1: Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) [Baseline (Day 1, Pre-dose) and 1, 24, 48 hours post-dose]

    Blood pressure was measured in supine position after 5 minutes rest. Change from Baseline in SBP and DBP was evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.

52. Part 2: Change From Baseline in SBP and DBP [Baseline (Day 1, Pre-dose) and 1, 24, 48 hours post-dose]

    Blood pressure was measured in supine position after 5 minutes rest. Change from Baseline in SBP and DBP was evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.

53. Part 1: Change From Baseline in Heart Rate [Baseline (Day 1, Pre-dose) and 1, 24, 48 hours post-dose]

    Heart rate was measured in supine position after 5 minutes rest. Change from Baseline in heart rate was evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.

54. Part 2: Change From Baseline in Heart Rate [Baseline (Day 1, Pre-dose) and 1, 24, 48 hours post-dose]

    Heart rate was measured in supine position after 5 minutes rest. Change from Baseline in heart rate was evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.

55. Part 1: Change From Baseline in Body Temperature [Baseline (Day 1, Pre-dose) and 1, 24, 48 hours post-dose]

    Body temperature was measured in supine position after 5 minutes rest. Change from Baseline in body temperature was evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.

56. Part 2: Change From Baseline in Body Temperature [Baseline (Day 1, Pre-dose) and 1, 24, 48 hours post-dose]

    Body temperature was measured in supine position after 5 minutes rest. Change from Baseline in body temperature was evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.

57. Part 1: Change From Baseline in Heart Rate (12-Lead Electrocardiogram [ECG]) [Baseline (Day 1, Pre-dose) and 1, 48 hours post-dose]

    Single 12-lead ECG was obtained using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and QT interval with Fridericia's correction (QTcF). Change from Baseline in heart rate (ECG) was evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.

58. Part 2: Change From Baseline in Heart Rate (ECG) [Baseline (Day 1, Pre-dose) and 1, 48 hours post-dose]

    Single 12-lead ECG was obtained using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and QTcF. Change from Baseline in heart rate (ECG) was evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.

59. Part 1: Change From Baseline in PR Interval, QRS Interval, QT Interval and QTcF Interval [Baseline (Day 1, Pre-dose) and 1, 48 hours post-dose]

    Single 12-lead ECG was obtained using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and QTcF. Change from Baseline in PR interval, QRS interval, QT interval and QTcF interval was evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.

60. Part 2: Change From Baseline in PR Interval, QRS Interval, QT Interval and QTcF Interval [Baseline (Day 1, Pre-dose) and 1, 48 hours post-dose]

    Single 12-lead ECG was obtained using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and QTcF. Change from Baseline in PR interval, QRS interval, QT interval and QTcF interval was evaluated. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 55 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Subjects must be 20 to 55 years of age inclusive, at the time of signing the informed consent.

• Japanese subjects who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring.

• Subjects with body weight of >= 50 kilogram (kg) and body mass index (BMI) within the range of >=18.5 and <25.0 kg per meter square (m^2).

• In male subjects contraceptive use should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.

• Male subjects are eligible to participate if they agree to the following during the intervention period and until the completion of follow-ups: Refrain from donating sperm; Be abstinent from heterosexual or homosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent; Agree to use a male condom and female partner to use an additional highly effective contraceptive method with a failure rate of <1 percentage per year when having sexual intercourse with a woman of childbearing potential who is not currently pregnant; Agree to use male condom when engaging in any activity that allows for passage of ejaculate to another person.

• Subjects must be non-smokers.

• Subjects capable of giving signed informed consent.

Exclusion Criteria:

• Subjects with history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention; or interfering with the interpretation of data.

• Subjects with abnormal blood pressure as determined by the investigator.

• Subjects with history of allergic rhinitis.

• Subjects with ALT >1.5x upper limit of normal (ULN).

• Subjects with bilirubin >1.5 times ULN (isolated bilirubin >1.5 times ULN is acceptable if bilirubin is fractionated and direct bilirubin <35 percentage).

• Subjects with current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).

• Subjects with QTc >450 millisecond (msec).

• Subjects with past or intended use of over-the-counter or prescription medication including vitamins, diet supplements (including St. John's wort), herbal medications within 14 days prior to first dosing or 5 half-lives (whichever is longer).

• Exposure to more than 4 new chemical entities within 12 months prior to the first dosing day.

• Current enrolment or past participation within 4 months prior to the first dosing day in this or any other clinical study involving an investigational study intervention or any other type of medical research (except for the subjects with no study intervention administered during any of those enrolment or participation).

• The subject with positive serological test for syphilis (Rapid Plasma Reagin [RPR] and Treponema pallidum [TP] antibody tests), Human immunodeficiency virus (HIV) Antigen/Antibody, Hepatitis B surface antigen (HBsAg), Hepatitis C virus (HCV) antibody, or Human T-cell lymphotropic virus type 1 (HTLV-1) antibody at screening.

• Subject with positive pre-study drug screen.

• Subject with regular moderate alcohol consumption within 6 months prior to the study participation defined as: An average weekly intake of >14 units for males. One unit is equivalent to 360 milliliter (mL) of beer, 150 mL of wine or 45 mL of 80 proof distilled of spirits.

• Smoking or history or regular use of tobacco- or nicotine-containing products within 6 months prior to screening.

• Sensitivity to any of the study interventions, or components thereof, or drug or other allergy that, in the opinion of the investigator or Medical Monitor, contraindicates participation in the study.

• History of donation of blood or blood products >= 400 mL within 3 months or >=200 mL within 1 month prior to the first dosing day.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	GSK Investigational Site	Fukuoka		Japan	812-0025

Sponsors and Collaborators

• GlaxoSmithKline
• Zensei Pharmaceutical Co., Ltd.

Investigators

• Study Director: GSK Clinical Trials, GlaxoSmithKline

Study Documents (Full-Text)

• Statistical Analysis Plan - May 15, 2018
• Study Protocol - Aug 1, 2018

More Information

Publications

None provided.

• Responsible Party: GlaxoSmithKline
• ClinicalTrials.gov Identifier: NCT03555890
• Other Study ID Numbers: 204706
• First Posted: Jun 14, 2018
• Last Update Posted: Jun 2, 2020
• Last Verified: May 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by GlaxoSmithKline: Oral disintegrating tablet; Levocetirizine; Immediate release tablet; Bioequivalence; Japanese subjects
• Additional relevant MeSH terms: Rhinitis; Cetirizine; Levocetirizine

Study Results

Participant Flow

Recruitment Details	This was a single center, single dose, open-label, randomized, 2-part, 2-way crossover study. Bioequivalence (BE) between levocetirizine (levo) oral disintegrating tablet (ODT) and levocetirizine immediate release tablet (IRT) was evaluated in 72 healthy Japanese participants.
Pre-assignment Detail	A total of 133 participants were screened, of them, 72 participants were randomized to receive study treatment. All participants except one participant randomized in Part 2 (Initial study) completed the study.

Arm/Group Title	Part 1: Levo IRT 5 mg Followed by Levo ODT 5 mg (With Water)	Part 1: Levo ODT 5 mg (With Water) Followed by Levo IRT 5 mg	Part 2:Levo IRT 5 mg Followed by Levo ODT 5 mg (Without Water)	Part 2:Levo ODT 5 mg (Without Water) Followed by Levo IRT 5 mg
Arm/Group Description	All participants received a single oral dose of levocetirizine IRT 5 milligram (mg) tablet with water in fasted state on Day 1 in Period 1. All participants received a single oral dose of levocetirizine ODT 5 mg tablet with water in fasted state on Day 1 in period 2. There was a washout period of at least 5 days between 2 periods.	All participants received a single oral dose of levocetirizine ODT 5 mg tablet with water in fasted state on Day 1 in Period 1. All participants received a single oral dose of levocetirizine IRT 5 mg tablet with water in fasted state on Day 1 in period 2. There was a washout period of at least 5 days between 2 periods.	All participants received a single oral dose of levocetirizine IRT 5 mg tablet with water in fasted state on Day 1 in Period 1. All participants received a single oral dose of levocetirizine ODT 5 mg tablet without water in fasted state on Day 1 in period 2. There was a washout period of at least 5 days between 2 periods.	All participants received a single oral dose of levocetirizine ODT 5 mg tablet without water in fasted state on Day 1 in Period 1. All participants received a single oral dose of levocetirizine IRT 5 mg tablet with water in fasted state on Day 1 in period 2. There was a washout period of at least 5 days between 2 periods.
Period Title: Part 1:Treatment Period 1 (3 Days)
STARTED	12	12	0	0
COMPLETED	12	12	0	0
NOT COMPLETED	0	0	0	0
Period Title: Part 1:Treatment Period 1 (3 Days)
STARTED	12	12	0	0
COMPLETED	12	12	0	0
NOT COMPLETED	0	0	0	0
Period Title: Part 1:Treatment Period 1 (3 Days)
STARTED	12	12	0	0
COMPLETED	12	12	0	0
NOT COMPLETED	0	0	0	0
Period Title: Part 1:Treatment Period 1 (3 Days)
STARTED	0	0	24	24
COMPLETED	0	0	24	24
NOT COMPLETED	0	0	0	0
Period Title: Part 1:Treatment Period 1 (3 Days)
STARTED	0	0	24	24
COMPLETED	0	0	24	23
NOT COMPLETED	0	0	0	1
Period Title: Part 1:Treatment Period 1 (3 Days)
STARTED	0	0	24	23
COMPLETED	0	0	24	23
NOT COMPLETED	0	0	0	0

Baseline Characteristics

Arm/Group Title	Part 1: Levo IRT 5 mg Followed by Levo ODT 5 mg (With Water)	Part 1: Levo ODT 5 mg (With Water) Followed by Levo IRT 5 mg	Part 2:Levo IRT 5 mg Followed by Levo ODT 5 mg (Without Water)	Part 2:Levo ODT 5 mg (Without Water) Followed by Levo IRT 5 mg	Total
Arm/Group Description	All participants received a single oral dose of levocetirizine IRT 5 milligram (mg) tablet with water in fasted state on Day 1 in Period 1. All participants received a single oral dose of levocetirizine ODT 5 mg tablet with water in fasted state on Day 1 in period 2. There was a washout period of at least 5 days between 2 periods.	All participants received a single oral dose of levocetirizine ODT 5 mg tablet with water in fasted state on Day 1 in Period 1. All participants received a single oral dose of levocetirizine IRT 5 mg tablet with water in fasted state on Day 1 in period 2. There was a washout period of at least 5 days between 2 periods.	All participants received a single oral dose of levocetirizine IRT 5 mg tablet with water in fasted state on Day 1 in Period 1. All participants received a single oral dose of levocetirizine ODT 5 mg tablet without water in fasted state on Day 1 in period 2. There was a washout period of at least 5 days between 2 periods.	All participants received a single oral dose of levocetirizine ODT 5 mg tablet without water in fasted state on Day 1 in Period 1. All participants received a single oral dose of levocetirizine IRT 5 mg tablet with water in fasted state on Day 1 in period 2. There was a washout period of at least 5 days between 2 periods.	Total of all reporting groups
Overall Participants	12	12	24	24	72
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	29.5 (6.72)	31.8 (8.93)	27.0 (7.00)	26.3 (6.48)	28.0 (7.27)
Sex: Female, Male (Count of Participants)
Female	0 0%	0 0%	0 0%	0 0%	0 0%
Male	12 100%	12 100%	24 100%	24 100%	72 100%
Race/Ethnicity, Customized (Count of Participants)
Asian-Japanese Heritage	12 100%	12 100%	24 100%	24 100%	72 100%

Outcome Measures

1. Primary Outcome

Title	Part 1: Area Under the Concentration-time Curve (AUC) From Time Zero Time (Pre-dose) to the Time of Last Quantifiable Concentration (AUC[0-t]) of Levocetirizine
Description	Blood samples were collected to measure AUC(0-t) at indicated time-points. AUC(0-t) was calculated by the linear trapezoidal method (i.e., Linear Trapezoidal Linear Interpolation calculation method in Phoenix WinNonlin).
Time Frame	Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48 hours post-dose

Outcome Measure Data

Analysis Population Description

Pharmacokinetic (PK) Population is defined as all participants who were administered at least one dose of study treatment and blood samples for plasma drug concentration were taken and analyzed.

Arm/Group Title	Part 1: Levocetirizine ODT 5 mg	Part 1: Levocetirizine IRT 5 mg
Arm/Group Description	All participants received a single oral dose of levocetirizine ODT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.	All participants received a single oral dose of levocetirizine IRT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.
Measure Participants	24	24
Geometric Mean (95% Confidence Interval) [Hours*nanogram per milliliter (Hr*ng/mL)]	1758.5	1803.2

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Part 1: Levocetirizine ODT 5 mg, Part 1: Levocetirizine IRT 5 mg
	Comments
	Type of Statistical Test	Equivalence
	Comments	If the 90 percent (%) confidence interval of the geometric mean ratio (Levocetirizine ODT/ Levocetirizine IRT) was within the acceptable range of 0.80 to 1.25 then Levocetirizine ODT was to be considered bioequivalent to the Levocetirizine IRT.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Ratio of geometric mean
	Estimated Value	0.975
	Confidence Interval	(2-Sided) 90%; 0.948 to 1.003
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Primary Outcome

Title	Part 2: AUC(0-t) of Levocetirizine
Description	Blood samples were collected to measure AUC(0-t) at indicated time-points. AUC(0-t) was calculated by the linear trapezoidal method (i.e., Linear Trapezoidal Linear Interpolation calculation method in Phoenix WinNonlin).
Time Frame	Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48 hours post-dose

Outcome Measure Data

Analysis Population Description

PK Population. Only those participants with data available at the specified data points were analyzed.

Arm/Group Title	Part 2: Levocetirizine ODT 5 mg	Part 2: Levocetirizine IRT 5 mg
Arm/Group Description	All participants received a single oral dose of levocetirizine ODT 5 mg tablet without water in fasted state either in Period 1 or Period 2 as per randomization schedule.	All participants received a single oral dose of levocetirizine IRT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.
Measure Participants	48	47
Geometric Mean (95% Confidence Interval) [Hr*ng/mL]	1809.9	1843.5

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Part 1: Levocetirizine ODT 5 mg, Part 1: Levocetirizine IRT 5 mg
	Comments
	Type of Statistical Test	Equivalence
	Comments	If the 90 percent (%) confidence interval of the geometric mean ratio (Levocetirizine ODT/ Levocetirizine IRT) was within the acceptable range of 0.80 to 1.25 then Levocetirizine ODT was to be considered bioequivalent to the Levocetirizine IRT.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Ratio of geometric mean
	Estimated Value	0.978
	Confidence Interval	(2-Sided) 90%; 0.958 to 0.998
	Parameter Dispersion	Type: Value:
	Estimation Comments

3. Primary Outcome

Title	Part 1: Maximum Observed Concentration (Cmax) of Levocetirizine
Description	Blood samples were collected at indicated time points for analysis of Cmax. The values for Cmax were obtained directly from the concentration-time data.
Time Frame	Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48 hours post-dose

Outcome Measure Data

Analysis Population Description

PK Population

Arm/Group Title	Part 1: Levocetirizine ODT 5 mg	Part 1: Levocetirizine IRT 5 mg
Arm/Group Description	All participants received a single oral dose of levocetirizine ODT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.	All participants received a single oral dose of levocetirizine IRT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.
Measure Participants	24	24
Geometric Mean (95% Confidence Interval) [Nanogram per milliliter (ng/mL)]	219.9	235.4

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Part 1: Levocetirizine ODT 5 mg, Part 1: Levocetirizine IRT 5 mg
	Comments
	Type of Statistical Test	Equivalence
	Comments	If the 90 percent (%) confidence interval of the geometric mean ratio (Levocetirizine ODT/ Levocetirizine IRT) was within the acceptable range of 0.80 to 1.25 then Levocetirizine ODT was to be considered bioequivalent to the Levocetirizine IRT.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Ratio of geometric mean
	Estimated Value	0.934
	Confidence Interval	(2-Sided) 90%; 0.875 to 0.998
	Parameter Dispersion	Type: Value:
	Estimation Comments

4. Primary Outcome

Title	Part 2: Cmax of Levocetirizine
Description	Blood samples were collected at indicated time points for analysis of Cmax. The values for Cmax were obtained directly from the concentration-time data.
Time Frame	Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48 hours post-dose

Outcome Measure Data

Analysis Population Description

PK Population. Only those participants with data available at the specified data points were analyzed.

Arm/Group Title	Part 2: Levocetirizine ODT 5 mg	Part 2: Levocetirizine IRT 5 mg
Arm/Group Description	All participants received a single oral dose of levocetirizine ODT 5 mg tablet without water in fasted state either in Period 1 or Period 2 as per randomization schedule.	All participants received a single oral dose of levocetirizine IRT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.
Measure Participants	48	47
Geometric Mean (95% Confidence Interval) [ng/mL]	191.5	223.6

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Part 1: Levocetirizine ODT 5 mg, Part 1: Levocetirizine IRT 5 mg
	Comments
	Type of Statistical Test	Equivalence
	Comments	If the 90 percent (%) confidence interval of the geometric mean ratio (Levocetirizine ODT/ Levocetirizine IRT) was within the acceptable range of 0.80 to 1.25 then Levocetirizine ODT was to be considered bioequivalent to the Levocetirizine IRT.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Ratio of geometric mean
	Estimated Value	0.857
	Confidence Interval	(2-Sided) 90%; 0.815 to 0.902
	Parameter Dispersion	Type: Value:
	Estimation Comments

5. Secondary Outcome

Title	Part 1: Area Under the Concentration-time Curve From Zero Time (Pre-dose) Extrapolated to Infinite Time AUC(0-inf) of Levocetirizine
Description	Blood samples were collected at indicated time points for analysis of AUC(0-inf). AUC(0-inf)) of levocetirizine was calculated by standard non-compartmental analysis using the currently supported version of WinNonlin (version 6.3 or higher).
Time Frame	Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36 and 48 hours post-dose

Outcome Measure Data

Analysis Population Description

PK Population

Arm/Group Title	Part 1: Levocetirizine ODT 5 mg	Part 1: Levocetirizine IRT 5 mg
Arm/Group Description	All participants received a single oral dose of levocetirizine ODT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.	All participants received a single oral dose of levocetirizine IRT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.
Measure Participants	24	24
Geometric Mean (95% Confidence Interval) [Hr*ng/mL]	1812.9	1852.5

6. Secondary Outcome

Title	Part 2: AUC(0-inf) of Levocetirizine
Description	Blood samples were collected at indicated time points for analysis of AUC(0-inf). AUC(0-inf) of levocetirizine was calculated by standard non-compartmental analysis using the currently supported version of WinNonlin (version 6.3 or higher).
Time Frame	Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36 and 48 hours post-dose

Outcome Measure Data

Analysis Population Description

PK Population. Only those participants with data available at the specified data points were analyzed.

Arm/Group Title	Part 2: Levocetirizine ODT 5 mg	Part 2: Levocetirizine IRT 5 mg
Arm/Group Description	All participants received a single oral dose of levocetirizine ODT 5 mg tablet without water in fasted state either in Period 1 or Period 2 as per randomization schedule.	All participants received a single oral dose of levocetirizine IRT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.
Measure Participants	48	47
Geometric Mean (95% Confidence Interval) [Hr*ng/mL]	1869.5	1900.2

7. Secondary Outcome

Title	Part 1: Time to First Occurrence of Cmax (Tmax) of Levocetirizine
Description	Blood samples were collected at indicated time points for analysis of tmax. The tmax of levocetirizine was obtained directly from the concentration-time data. The tmax was analyzed with the non-parametric Wilcoxon Matched Pairs Method (Signed Rank Method) to compute point estimate and associated 90% confidence interval for the median difference.
Time Frame	Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36 and 48 hours post-dose

Outcome Measure Data

Analysis Population Description

PK Population

Arm/Group Title	Part 1: Levocetirizine ODT 5 mg	Part 1: Levocetirizine IRT 5 mg
Arm/Group Description	All participants received a single oral dose of levocetirizine ODT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.	All participants received a single oral dose of levocetirizine IRT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.
Measure Participants	24	24
Median (Full Range) [Hours]	0.5000	0.7500

8. Secondary Outcome

Title	Part 2: Tmax of Levocetirizine
Description	Blood samples were collected at indicated time points for analysis of tmax. The tmax of levocetirizine was obtained directly from the concentration-time data. The tmax was analyzed with the non-parametric Wilcoxon Matched Pairs Method (Signed Rank Method) to compute point estimate and associated 90% confidence interval for the median difference.
Time Frame	Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36 and 48 hours post-dose

Outcome Measure Data

Analysis Population Description

PK Population. Only those participants with data available at the specified data points were analyzed.

Arm/Group Title	Part 2: Levocetirizine ODT 5 mg	Part 2: Levocetirizine IRT 5 mg
Arm/Group Description	All participants received a single oral dose of levocetirizine ODT 5 mg tablet without water in fasted state either in Period 1 or Period 2 as per randomization schedule.	All participants received a single oral dose of levocetirizine IRT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.
Measure Participants	48	47
Median (Full Range) [Hours]	1.0000	1.0000

9. Secondary Outcome

Title	Part 1: Apparent Terminal Phase Half-life (t1/2) of Levocetirizine
Description	Blood samples were collected at indicated time points for analysis of t1/2. The t1/2 of levocetirizine was calculated by standard non-compartmental analysis using the currently supported version of WinNonlin (version 6.3 or higher).
Time Frame	Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36 and 48 hours post-dose

Outcome Measure Data

Analysis Population Description

PK Population

Arm/Group Title	Part 1: Levocetirizine ODT 5 mg	Part 1: Levocetirizine IRT 5 mg
Arm/Group Description	All participants received a single oral dose of levocetirizine ODT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.	All participants received a single oral dose of levocetirizine IRT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.
Measure Participants	24	24
Geometric Mean (95% Confidence Interval) [Hours]	8.784	8.544

10. Secondary Outcome

Title	Part 2: t1/2 of Levocetirizine
Description	Blood samples were collected at indicated time points for analysis of t1/2. The t1/2 of levocetirizine was calculated by standard non-compartmental analysis using the currently supported version of WinNonlin (version 6.3 or higher).
Time Frame	Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36 and 48 hours post-dose

Outcome Measure Data

Analysis Population Description

PK Population. Only those participants with data available at the specified data points were analyzed.

Arm/Group Title	Part 2: Levocetirizine ODT 5 mg	Part 2: Levocetirizine IRT 5 mg
Arm/Group Description	All participants received a single oral dose of levocetirizine ODT 5 mg tablet without water in fasted state either in Period 1 or Period 2 as per randomization schedule.	All participants received a single oral dose of levocetirizine IRT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.
Measure Participants	48	47
Geometric Mean (95% Confidence Interval) [Hours]	9.024	8.933

11. Secondary Outcome

Title	Part 1: Percentage of AUC(0-inf) Obtained by Extrapolation (%AUCex) of Levocetirizine
Description	Blood samples were collected at indicated time points for analysis of %AUCex. Percentage AUCex of levocetirizine was calculated by standard non-compartmental analysis using the currently supported version of WinNonlin (version 6.3 or higher).
Time Frame	Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36 and 48 hours post-dose

Outcome Measure Data

Analysis Population Description

PK Population

Arm/Group Title	Part 1: Levocetirizine ODT 5 mg	Part 1: Levocetirizine IRT 5 mg
Arm/Group Description	All participants received a single oral dose of levocetirizine ODT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.	All participants received a single oral dose of levocetirizine IRT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.
Measure Participants	24	24
Geometric Mean (95% Confidence Interval) [Percentage AUCex]	2.772	2.500

12. Secondary Outcome

Title	Part 2: %AUCex of Levocetirizine
Description	Blood samples were collected at indicated time points for analysis of %AUCex. Percentage AUCex of levocetirizine was calculated by standard non-compartmental analysis using the currently supported version of WinNonlin (version 6.3 or higher).
Time Frame	Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36 and 48 hours post-dose

Outcome Measure Data

Analysis Population Description

PK Population. Only those participants with data available at the specified data points were analyzed.

Arm/Group Title	Part 2: Levocetirizine ODT 5 mg	Part 2: Levocetirizine IRT 5 mg
Arm/Group Description	All participants received a single oral dose of levocetirizine ODT 5 mg tablet without water in fasted state either in Period 1 or Period 2 as per randomization schedule.	All participants received a single oral dose of levocetirizine IRT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.
Measure Participants	48	47
Geometric Mean (95% Confidence Interval) [Percentage AUCex]	2.973	2.779

13. Secondary Outcome

Title	Part 1: Apparent Clearance Following Oral Dosing (CL/F) of Levocetirizine
Description	Blood samples were collected at indicated time points for analysis of CL/F. CL/F of levocetirizine was calculated by standard non-compartmental analysis using the currently supported version of WinNonlin (version 6.3 or higher).
Time Frame	Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36 and 48 hours post-dose

Outcome Measure Data

Analysis Population Description

PK Population

Arm/Group Title	Part 1: Levocetirizine ODT 5 mg	Part 1: Levocetirizine IRT 5 mg
Arm/Group Description	All participants received a single oral dose of levocetirizine ODT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.	All participants received a single oral dose of levocetirizine IRT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.
Measure Participants	24	24
Geometric Mean (95% Confidence Interval) [Liters per hour]	2.758	2.699

14. Secondary Outcome

Title	Part 2: CL/F of Levocetirizine
Description	Blood samples were collected at indicated time points for analysis of CL/F. CL/F of levocetirizine was calculated by standard non-compartmental analysis using the currently supported version of WinNonlin (version 6.3 or higher).
Time Frame	Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36 and 48 hours post-dose

Outcome Measure Data

Analysis Population Description

PK Population. Only those participants with data available at the specified data points were analyzed.

Arm/Group Title	Part 2: Levocetirizine ODT 5 mg	Part 2: Levocetirizine IRT 5 mg
Arm/Group Description	All participants received a single oral dose of levocetirizine ODT 5 mg tablet without water in fasted state either in Period 1 or Period 2 as per randomization schedule.	All participants received a single oral dose of levocetirizine IRT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.
Measure Participants	48	47
Geometric Mean (95% Confidence Interval) [Liters per hour]	2.675	2.631

15. Secondary Outcome

Title	Part 1: Apparent Volume of Distribution Following Oral Dosing (Vz/F) of Levocetirizine
Description	Blood samples were collected at indicated time points for analysis of Vz/F. Vz/F of levocetirizine was calculated by standard non-compartmental analysis using the currently supported version of WinNonlin (version 6.3 or higher).
Time Frame	Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36 and 48 hours post-dose

Outcome Measure Data

Analysis Population Description

PK Population

Arm/Group Title	Part 1: Levocetirizine ODT 5 mg	Part 1: Levocetirizine IRT 5 mg
Arm/Group Description	All participants received a single oral dose of levocetirizine ODT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.	All participants received a single oral dose of levocetirizine IRT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.
Measure Participants	24	24
Geometric Mean (95% Confidence Interval) [Liters]	34.95	33.27

16. Secondary Outcome

Title	Part 2: Vz/F of Levocetirizine
Description	Blood samples were collected at indicated time points for analysis of Vz/F. Vz/F of levocetirizine was calculated as by standard non-compartmental analysis using the currently supported version of WinNonlin (version 6.3 or higher).
Time Frame	Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36 and 48 hours post-dose

Outcome Measure Data

Analysis Population Description

PK Population. Only those participants with data available at the specified data points were analyzed.

Arm/Group Title	Part 2: Levocetirizine ODT 5 mg	Part 2: Levocetirizine IRT 5 mg
Arm/Group Description	All participants received a single oral dose of levocetirizine ODT 5 mg tablet without water in fasted state either in Period 1 or Period 2 as per randomization schedule.	All participants received a single oral dose of levocetirizine IRT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.
Measure Participants	48	47
Geometric Mean (95% Confidence Interval) [Liters]	34.82	33.91

17. Secondary Outcome

Title	Part 1: Elimination Rate Constant (Kel) (lambda_z) of Levocetirizine
Description	Blood samples were collected at indicated time points for analysis of kel. kel (lambda_z) is the first order rate constant associated with the terminal (log-linear) portion of the curve. kel of levocetirizine was calculated by standard non-compartmental analysis using the currently supported version of WinNonlin (version 6.3 or higher).
Time Frame	Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36 and 48 hours post-dose

Outcome Measure Data

Analysis Population Description

PK Population

Arm/Group Title	Part 1: Levocetirizine ODT 5 mg	Part 1: Levocetirizine IRT 5 mg
Arm/Group Description	All participants received a single oral dose of levocetirizine ODT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.	All participants received a single oral dose of levocetirizine IRT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.
Measure Participants	24	24
Geometric Mean (95% Confidence Interval) [Per hour]	0.07891	0.08113

18. Secondary Outcome

Title	Part 2: Kel (lambda_z) of Levocetirizine
Description	Blood samples were collected at indicated time points for analysis of kel. kel (lambda_z) is the first order rate constant associated with the terminal (log-linear) portion of the curve. kel of levocetirizine was calculated by standard non-compartmental analysis using the currently supported version of WinNonlin (version 6.3 or higher).
Time Frame	Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36 and 48 hours post-dose

Outcome Measure Data

Analysis Population Description

PK Population. Only those participants with data available at the specified data points were analyzed.

Arm/Group Title	Part 2: Levocetirizine ODT 5 mg	Part 2: Levocetirizine IRT 5 mg
Arm/Group Description	All participants received a single oral dose of levocetirizine ODT 5 mg tablet without water in fasted state either in Period 1 or Period 2 as per randomization schedule.	All participants received a single oral dose of levocetirizine IRT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.
Measure Participants	48	47
Geometric Mean (95% Confidence Interval) [Per hour]	0.07681	0.07760

19. Secondary Outcome

Title	Part 1: Mean Residence Time (MRT) of Levocetirizine
Description	Blood samples were collected at indicated time points for analysis of MRT. MRT of levocetirizine was calculated by standard non-compartmental analysis using the currently supported version of WinNonlin (version 6.3 or higher).
Time Frame	Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36 and 48 hours post-dose

Outcome Measure Data

Analysis Population Description

PK Population

Arm/Group Title	Part 1: Levocetirizine ODT 5 mg	Part 1: Levocetirizine IRT 5 mg
Arm/Group Description	All participants received a single oral dose of levocetirizine ODT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.	All participants received a single oral dose of levocetirizine IRT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.
Measure Participants	24	24
Geometric Mean (95% Confidence Interval) [Hours]	11.545	11.417

20. Secondary Outcome

Title	Part 2: MRT of Levocetirizine
Description	Blood samples were collected at indicated time points for analysis of MRT. MRT of levocetirizine was calculated by standard non-compartmental analysis using the currently supported version of WinNonlin (version 6.3 or higher).
Time Frame	Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36 and 48 hours post-dose

Outcome Measure Data

Analysis Population Description

PK Population. Only those participants with data available at the specified data points were analyzed.

Arm/Group Title	Part 2: Levocetirizine ODT 5 mg	Part 2: Levocetirizine IRT 5 mg
Arm/Group Description	All participants received a single oral dose of levocetirizine ODT 5 mg tablet without water in fasted state either in Period 1 or Period 2 as per randomization schedule.	All participants received a single oral dose of levocetirizine IRT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.
Measure Participants	48	47
Geometric Mean (95% Confidence Interval) [Hours]	12.573	12.272

21. Secondary Outcome

Title	Part 1: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Description	An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. A SAE is defined as any untoward medical occurrence that, at any dose may results in death or is life-threatening or requires inpatient hospitalization or results in persistent disability/incapacity or is a congenital anomaly/birth defect or any other situation according to medical or scientific judgment.
Time Frame	Up to 18 days

Outcome Measure Data

Analysis Population Description

Safety Population consists of all participants who were administered at least one dose of study treatment.

Arm/Group Title	Part 1: Levocetirizine ODT 5 mg	Part 1: Levocetirizine IRT 5 mg
Arm/Group Description	All participants received a single oral dose of levocetirizine ODT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.	All participants received a single oral dose of levocetirizine IRT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.
Measure Participants	24	24
AEs	0 0%	0 0%
SAEs	0 0%	0 0%

22. Secondary Outcome

Title	Part 2: Number of Participants With AEs and SAEs
Description	An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. A SAE is defined as any untoward medical occurrence that, at any dose may results in death or is life-threatening or requires inpatient hospitalization or results in persistent disability/incapacity or is a congenital anomaly/birth defect or any other situation according to medical or scientific judgment.
Time Frame	Up to 18 days

Outcome Measure Data

Analysis Population Description

Safety Population. Only those participants with data available at the specified data points were analyzed.

Arm/Group Title	Part 2: Levocetirizine ODT 5 mg	Part 2: Levocetirizine IRT 5 mg
Arm/Group Description	All participants received a single oral dose of levocetirizine ODT 5 mg tablet without water in fasted state either in Period 1 or Period 2 as per randomization schedule.	All participants received a single oral dose of levocetirizine IRT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.
Measure Participants	48	47
AEs	6 50%	0 0%
SAEs	0 0%	0 0%

23. Secondary Outcome

Title	Part 1: Change From Baseline in Albumin and Total Protein Levels
Description	Blood samples were collected for the assessment of clinical chemistry parameters. Change from Baseline in albumin and total protein levels were evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Time Frame	Baseline (Day 1, Pre-dose) and 48 hours post-dose

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	Part 1: Levocetirizine ODT 5 mg	Part 1: Levocetirizine IRT 5 mg
Arm/Group Description	All participants received a single oral dose of levocetirizine ODT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.	All participants received a single oral dose of levocetirizine IRT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.
Measure Participants	24	24
Albumin	1.6 (1.64)	1.5 (1.59)
Total protein	2.7 (2.16)	2.3 (2.26)

24. Secondary Outcome

Title	Part 2: Change From Baseline in Albumin and Total Protein Levels
Description	Blood samples were collected for the assessment of clinical chemistry parameters. Change from Baseline in albumin and total protein levels were evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Time Frame	Baseline (Day 1, Pre-dose) and 48 hours post-dose

Outcome Measure Data

Analysis Population Description

Safety Population. Only those participants with data available at the specified data points were analyzed.

Arm/Group Title	Part 2: Levocetirizine ODT 5 mg	Part 2: Levocetirizine IRT 5 mg
Arm/Group Description	All participants received a single oral dose of levocetirizine ODT 5 mg tablet without water in fasted state either in Period 1 or Period 2 as per randomization schedule.	All participants received a single oral dose of levocetirizine IRT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.
Measure Participants	48	47
Albumin	1.2 (2.08)	1.4 (2.17)
Total protein	1.8 (3.02)	1.9 (3.34)

25. Secondary Outcome

Title	Part 1: Change From Baseline in Alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatine Kinase, Gamma Glutamyl Transferase and Lactate Dehydrogenase Levels
Description	Blood samples were collected for the assessment of clinical chemistry parameters. Change from Baseline in alkaline phosphatase, alanine amino transferase, aspartate amino transferase, creatine kinase, gamma glutamyl transferase and lactate dehydrogenase levels were evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Time Frame	Baseline (Day 1, Pre-dose) and 48 hours post-dose

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	Part 1: Levocetirizine ODT 5 mg	Part 1: Levocetirizine IRT 5 mg
Arm/Group Description	All participants received a single oral dose of levocetirizine ODT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.	All participants received a single oral dose of levocetirizine IRT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.
Measure Participants	24	24
Alkaline phosphatase	-0.8 (8.08)	-1.6 (7.81)
Alanine amino transferase	0.5 (3.51)	1.0 (3.32)
Aspartate amino transferase	-0.1 (2.81)	-0.3 (2.05)
Creatine kinase	-10.0 (29.62)	-13.2 (11.77)
Gamma glutamyl transferase	-0.6 (1.06)	-0.5 (1.82)
Lactate dehydrogenase	-11.0 (21.05)	-8.8 (10.10)

26. Secondary Outcome

Title	Part 2: Change From Baseline in Alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatine Kinase, Gamma Glutamyl Transferase and Lactate Dehydrogenase Levels
Description	Blood samples were collected for the assessment of clinical chemistry parameters. Change from Baseline in alkaline phosphatase, alanine amino transferase, aspartate amino transferase, creatine kinase, gamma glutamyl transferase and lactate dehydrogenase levels were evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Time Frame	Baseline (Day 1, Pre-dose) and 48 hours post-dose

Outcome Measure Data

Analysis Population Description

Safety Population. Only those participants with data available at the specified data points were analyzed.

Arm/Group Title	Part 2: Levocetirizine ODT 5 mg	Part 2: Levocetirizine IRT 5 mg
Arm/Group Description	All participants received a single oral dose of levocetirizine ODT 5 mg tablet without water in fasted state either in Period 1 or Period 2 as per randomization schedule.	All participants received a single oral dose of levocetirizine IRT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.
Measure Participants	48	47
Alkaline phosphatase	-1.1 (13.46)	-2.3 (14.17)
Alanine amino transferase	-0.5 (2.05)	-0.7 (2.63)
Aspartate amino transferase	0.1 (1.65)	-0.1 (2.58)
Creatine kinase	-12.4 (16.24)	-16.3 (20.93)
Gamma glutamyl transferase	-0.1 (1.28)	-0.1 (1.52)
Lactate dehydrogenase	-3.5 (10.52)	-3.7 (11.55)

27. Secondary Outcome

Title	Part 1: Change From Baseline in Amylase Levels
Description	Blood samples were collected for the assessment of clinical chemistry parameters. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Time Frame	Baseline (Day 1, Pre-dose) and 48 hours post-dose

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	Part 1: Levocetirizine ODT 5 mg	Part 1: Levocetirizine IRT 5 mg
Arm/Group Description	All participants received a single oral dose of levocetirizine ODT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.	All participants received a single oral dose of levocetirizine IRT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.
Measure Participants	24	24
Mean (Standard Deviation) [Units per liter (U/L)]	6.3 (7.94)	7.2 (10.62)

28. Secondary Outcome

Title	Part 2: Change From Baseline in Amylase Levels
Description	Blood samples were collected for the assessment of clinical chemistry parameters. Change from Baseline in amylase levels were evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Time Frame	Baseline (Day 1, Pre-dose) and 48 hours post-dose

Outcome Measure Data

Analysis Population Description

Safety Population. Only those participants with data available at the specified data points were analyzed.

Arm/Group Title	Part 2: Levocetirizine ODT 5 mg	Part 2: Levocetirizine IRT 5 mg
Arm/Group Description	All participants received a single oral dose of levocetirizine ODT 5 mg tablet without water in fasted state either in Period 1 or Period 2 as per randomization schedule.	All participants received a single oral dose of levocetirizine IRT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.
Measure Participants	48	47
Mean (Standard Deviation) [U/L]	7.4 (6.69)	7.1 (10.13)

29. Secondary Outcome

Title	Part 1: Change From Baseline in Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid Levels
Description	Blood samples were collected for the assessment of clinical chemistry parameters. Change from Baseline in direct bilirubin, total bilirubin, creatinine and uric acid levels were evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Time Frame	Baseline (Day 1, Pre-dose) and 48 hours post-dose

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	Part 1: Levocetirizine ODT 5 mg	Part 1: Levocetirizine IRT 5 mg
Arm/Group Description	All participants received a single oral dose of levocetirizine ODT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.	All participants received a single oral dose of levocetirizine IRT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.
Measure Participants	24	24
Direct bilirubin	0.214 (0.9178)	0.356 (1.0059)
Total bilirubin	0.143 (3.3034)	-1.710 (4.0340)
Creatinine	-1.9522 (4.20313)	-1.9890 (4.09064)
Uric acid	21.0658 (22.25394)	23.2963 (27.33699)

30. Secondary Outcome

Title	Part 2: Change From Baseline in Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid Levels
Description	Blood samples were collected for the assessment of clinical chemistry parameters. Change from Baseline in direct bilirubin, total bilirubin, creatinine and uric acid levels were evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Time Frame	Baseline (Day 1, Pre-dose) and 48 hours post-dose

Outcome Measure Data

Analysis Population Description

Safety Population. Only those participants with data available at the specified data points were analyzed.

Arm/Group Title	Part 2: Levocetirizine ODT 5 mg	Part 2: Levocetirizine IRT 5 mg
Arm/Group Description	All participants received a single oral dose of levocetirizine ODT 5 mg tablet without water in fasted state either in Period 1 or Period 2 as per randomization schedule.	All participants received a single oral dose of levocetirizine IRT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.
Measure Participants	48	47
Direct bilirubin	-0.071 (0.7018)	0.036 (0.7555)
Total bilirubin	-0.748 (3.0325)	-0.619 (3.1374)
Creatinine	-3.5913 (4.21949)	-3.8746 (5.00254)
Uric acid	14.0026 (20.14225)	13.6677 (28.30678)

31. Secondary Outcome

Title	Part 1: Change From Baseline in Calcium, Cholesterol, Chloride, Glucose, High Density Lipids Cholesterol, Potassium, Low Density Lipids Cholesterol, Sodium, Phosphorus Inorganic, Triglycerides and Urea/Blood Urea Nitrogen (BUN) Levels
Description	Blood samples were collected for the assessment of clinical chemistry parameters. Change from Baseline in calcium, cholesterol, chloride, glucose, high density lipids cholesterol, potassium, low density lipids cholesterol, sodium, phosphorus inorganic, triglycerides and urea/blood urea nitrogen (BUN) levels were evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Time Frame	Baseline (Day 1, Pre-dose) and 48 hours post-dose

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	Part 1: Levocetirizine ODT 5 mg	Part 1: Levocetirizine IRT 5 mg
Arm/Group Description	All participants received a single oral dose of levocetirizine ODT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.	All participants received a single oral dose of levocetirizine IRT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.
Measure Participants	24	24
Calcium	0.032227 (0.0490682)	0.018713 (0.0594308)
Cholesterol	0.117448 (0.2967150)	0.054953 (0.2589722)
Chloride	-0.9 (1.19)	-1.0 (1.43)
Glucose	-0.067075 (0.2724243)	-0.050884 (0.2037377)
High density lipids cholesterol	-0.032325 (0.1006621)	-0.063573 (0.0806953)
Potassium	0.13 (0.311)	0.10 (0.330)
Low density lipids cholesterol	0.059263 (0.2661881)	0.038790 (0.2158221)
Sodium	-0.6 (1.24)	-0.7 (1.49)
Phosphorus inorganic	-0.193740 (0.0737556)	-0.182977 (0.0849880)
Triglycerides	0.04520 (0.284839)	-0.00047 (0.304261)
Urea/BUN	0.01934 (0.472088)	0.08033 (0.498940)

32. Secondary Outcome

Title	Part 2: Change From Baseline in Calcium, Cholesterol, Chloride, Glucose, High Density Lipids Cholesterol, Potassium, Low Density Lipids Cholesterol, Sodium, Phosphorus Inorganic, Triglycerides and Urea/BUN Levels
Description	Blood samples were collected for the assessment of clinical chemistry parameters. Change from Baseline in calcium, cholesterol, chloride, glucose, high density lipids cholesterol, potassium, low density lipids cholesterol, sodium, phosphorus inorganic, triglycerides and urea/BUN levels were evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Time Frame	Baseline (Day 1, Pre-dose) and 48 hours post-dose

Outcome Measure Data

Analysis Population Description

Safety Population. Only those participants with data available at the specified data points were analyzed.

Arm/Group Title	Part 2: Levocetirizine ODT 5 mg	Part 2: Levocetirizine IRT 5 mg
Arm/Group Description	All participants received a single oral dose of levocetirizine ODT 5 mg tablet without water in fasted state either in Period 1 or Period 2 as per randomization schedule.	All participants received a single oral dose of levocetirizine IRT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.
Measure Participants	48	47
Calcium	0.015594 (0.0623219)	0.015926 (0.0704590)
Cholesterol	0.083506 (0.2666316)	0.064925 (0.2594347)
Chloride	-0.6 (1.17)	-0.5 (1.35)
Glucose	-0.049728 (0.2525006)	0.059053 (0.2990211)
High density lipids cholesterol	-0.049565 (0.1151357)	-0.047869 (0.0975044)
Potassium	-0.03 (0.233)	0.08 (0.368)
Low density lipids cholesterol	0.123374 (0.1986158)	0.084733 (0.1846539)
Sodium	-1.1 (1.28)	-0.6 (1.05)
Phosphorus inorganic	-0.203831 (0.1251750)	-0.239770 (0.1230018)
Triglycerides	-0.02707 (0.290907)	0.03606 (0.206604)
Urea/BUN	-0.12272 (0.622969)	-0.45802 (0.817628)

33. Secondary Outcome

Title	Part 1: Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes and Total Neutrophils Count
Description	Blood samples were collected for the assessment of hematology parameters. Change from Baseline in basophils, eosinophils, lymphocytes, monocytes and total neutrophils levels were evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Time Frame	Baseline (Day 1, Pre-dose) and 48 hours post-dose

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	Part 1: Levocetirizine ODT 5 mg	Part 1: Levocetirizine IRT 5 mg
Arm/Group Description	All participants received a single oral dose of levocetirizine ODT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.	All participants received a single oral dose of levocetirizine IRT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.
Measure Participants	24	24
Basophils	-0.01 (0.150)	0.01 (0.212)
Eosinophils	-0.53 (0.783)	-0.52 (1.087)
Lymphocytes	-5.94 (6.330)	-5.96 (7.705)
Monocytes	-0.16 (0.835)	0.16 (1.443)
Total neutrophils levels	6.64 (6.480)	6.32 (7.950)

34. Secondary Outcome

Title	Part 2: Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes and Total Neutrophils Count
Description	Blood samples were collected for the assessment of hematology parameters. Change from Baseline in basophils, eosinophils, lymphocytes, monocytes and total neutrophils levels were evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Time Frame	Baseline (Day 1, Pre-dose) and 48 hours post-dose

Outcome Measure Data

Analysis Population Description

Safety Population. Only those participants with data available at the specified data points were analyzed.

Arm/Group Title	Part 2: Levocetirizine ODT 5 mg	Part 2: Levocetirizine IRT 5 mg
Arm/Group Description	All participants received a single oral dose of levocetirizine ODT 5 mg tablet without water in fasted state either in Period 1 or Period 2 as per randomization schedule.	All participants received a single oral dose of levocetirizine IRT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.
Measure Participants	48	47
Basophils	0.08 (0.195)	0.04 (0.176)
Eosinophils	-0.92 (1.183)	-0.74 (1.012)
Lymphocytes	-8.45 (6.915)	-8.07 (5.558)
Monocytes	-0.49 (1.046)	-0.48 (1.087)
Total neutrophils levels	9.78 (7.094)	9.25 (5.847)

35. Secondary Outcome

Title	Part 1: Change From Baseline in Platelet Count and White Blood Cell Count
Description	Blood samples were collected for the assessment of hematology parameters. Change from Baseline in platelet count and white blood cell count were evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Time Frame	Baseline (Day 1, Pre-dose) and 48 hours post-dose

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	Part 1: Levocetirizine ODT 5 mg	Part 1: Levocetirizine IRT 5 mg
Arm/Group Description	All participants received a single oral dose of levocetirizine ODT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.	All participants received a single oral dose of levocetirizine IRT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.
Measure Participants	24	24
Platelet count	-6.4 (12.62)	-11.4 (11.64)
White blood cell count	-0.94 (0.950)	-1.26 (0.596)

36. Secondary Outcome

Title	Part 2: Change From Baseline in Platelet Count and White Blood Cell Count
Description	Blood samples were collected for the assessment of hematology parameters. Change from Baseline in platelet count and white blood cell count were evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Time Frame	Baseline (Day 1, Pre-dose) and 48 hours post-dose

Outcome Measure Data

Analysis Population Description

Safety Population. Only those participants with data available at the specified data points were analyzed.

Arm/Group Title	Part 2: Levocetirizine ODT 5 mg	Part 2: Levocetirizine IRT 5 mg
Arm/Group Description	All participants received a single oral dose of levocetirizine ODT 5 mg tablet without water in fasted state either in Period 1 or Period 2 as per randomization schedule.	All participants received a single oral dose of levocetirizine IRT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.
Measure Participants	48	47
Platelet count	-2.5 (12.71)	-2.9 (13.98)
White blood cell count	-1.14 (1.246)	-1.06 (1.133)

37. Secondary Outcome

Title	Part 1: Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration
Description	Blood samples were collected for the assessment of hematology parameters. Change from Baseline in hemoglobin and mean corpuscle hemoglobin concentration were evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Time Frame	Baseline (Day 1, Pre-dose) and 48 hours post-dose

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	Part 1: Levocetirizine ODT 5 mg	Part 1: Levocetirizine IRT 5 mg
Arm/Group Description	All participants received a single oral dose of levocetirizine ODT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.	All participants received a single oral dose of levocetirizine IRT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.
Measure Participants	24	24
Hemoglobin	2.2 (3.81)	2.3 (3.44)
Mean corpuscle hemoglobin concentration	2.3 (4.16)	1.8 (4.64)

38. Secondary Outcome

Title	Part 2: Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration
Description	Blood samples were collected for the assessment of hematology parameters. Change from Baseline in hemoglobin and mean corpuscle hemoglobin concentration were evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Time Frame	Baseline (Day 1, Pre-dose) and 48 hours post-dose

Outcome Measure Data

Analysis Population Description

Safety Population. Only those participants with data available at the specified data points were analyzed.

Arm/Group Title	Part 2: Levocetirizine ODT 5 mg	Part 2: Levocetirizine IRT 5 mg
Arm/Group Description	All participants received a single oral dose of levocetirizine ODT 5 mg tablet without water in fasted state either in Period 1 or Period 2 as per randomization schedule.	All participants received a single oral dose of levocetirizine IRT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.
Measure Participants	48	47
Hemoglobin	0.9 (4.87)	0.9 (5.69)
Mean corpuscle hemoglobin concentration	0.2 (4.12)	0.5 (3.87)

39. Secondary Outcome

Title	Part 1: Change Form Baseline in Hematocrit
Description	Blood samples were collected for the assessment of hematology parameters. Change from Baseline in hematocrit was evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Time Frame	Baseline (Day 1, Pre-dose) and 48 hours post-dose

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	Part 1: Levocetirizine ODT 5 mg	Part 1: Levocetirizine IRT 5 mg
Arm/Group Description	All participants received a single oral dose of levocetirizine ODT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.	All participants received a single oral dose of levocetirizine IRT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.
Measure Participants	24	24
Mean (Standard Deviation) [Proportion of red blood cells in blood]	0.0036 (0.01014)	0.0043 (0.00952)

40. Secondary Outcome

Title	Part 2: Change Form Baseline in Hematocrit
Description	Blood samples were collected for the assessment of hematology parameters. Change from Baseline in hematocrit was evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Time Frame	Baseline (Day 1, Pre-dose) and 48 hours post-dose

Outcome Measure Data

Analysis Population Description

Safety Population. Only those participants with data available at the specified data points were analyzed.

Arm/Group Title	Part 2: Levocetirizine ODT 5 mg	Part 2: Levocetirizine IRT 5 mg
Arm/Group Description	All participants received a single oral dose of levocetirizine ODT 5 mg tablet without water in fasted state either in Period 1 or Period 2 as per randomization schedule.	All participants received a single oral dose of levocetirizine IRT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.
Measure Participants	48	47
Mean (Standard Deviation) [Proportion of red blood cells in blood]	0.0023 (0.01505)	0.0019 (0.01595)

41. Secondary Outcome

Title	Part 1: Change From Baseline in Mean Corpuscle Hemoglobin
Description	Blood samples were collected for the assessment of hematology parameters. Change from Baseline in mean corpuscle hemoglobin was evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Time Frame	Baseline (Day 1, Pre-dose) and 48 hours post-dose

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	Part 1: Levocetirizine ODT 5 mg	Part 1: Levocetirizine IRT 5 mg
Arm/Group Description	All participants received a single oral dose of levocetirizine ODT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.	All participants received a single oral dose of levocetirizine IRT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.
Measure Participants	24	24
Mean (Standard Deviation) [Picograms]	-0.04 (0.313)	-0.03 (0.288)

42. Secondary Outcome

Title	Part 2: Change From Baseline in Mean Corpuscle Hemoglobin
Description	Blood samples were collected for the assessment of hematology parameters. Change from Baseline in mean corpuscle hemoglobin was evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Time Frame	Baseline (Day 1, Pre-dose) and 48 hours post-dose

Outcome Measure Data

Analysis Population Description

Safety Population. Only those participants with data available at the specified data points were analyzed.

Arm/Group Title	Part 2: Levocetirizine ODT 5 mg	Part 2: Levocetirizine IRT 5 mg
Arm/Group Description	All participants received a single oral dose of levocetirizine ODT 5 mg tablet without water in fasted state either in Period 1 or Period 2 as per randomization schedule.	All participants received a single oral dose of levocetirizine IRT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.
Measure Participants	48	47
Mean (Standard Deviation) [Picograms]	-0.07 (0.305)	-0.07 (0.265)

43. Secondary Outcome

Title	Part 1: Change From Baseline in Mean Corpuscle Volume
Description	Blood samples were collected for the assessment of hematology parameters. Change from Baseline in mean corpuscle volume was evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Time Frame	Baseline (Day 1, Pre-dose) and 48 hours post-dose

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	Part 1: Levocetirizine ODT 5 mg	Part 1: Levocetirizine IRT 5 mg
Arm/Group Description	All participants received a single oral dose of levocetirizine ODT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.	All participants received a single oral dose of levocetirizine IRT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.
Measure Participants	24	24
Mean (Standard Deviation) [Femtoliters]	-0.6 (0.83)	-0.5 (0.83)

44. Secondary Outcome

Title	Part 2: Change From Baseline in Mean Corpuscle Volume
Description	Blood samples were collected for the assessment of hematology parameters. Change from Baseline in mean corpuscle volume was evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Time Frame	Baseline (Day 1, Pre-dose) and 48 hours post-dose

Outcome Measure Data

Analysis Population Description

Safety Population. Only those participants with data available at the specified data points were analyzed.

Arm/Group Title	Part 2: Levocetirizine ODT 5 mg	Part 2: Levocetirizine IRT 5 mg
Arm/Group Description	All participants received a single oral dose of levocetirizine ODT 5 mg tablet without water in fasted state either in Period 1 or Period 2 as per randomization schedule.	All participants received a single oral dose of levocetirizine IRT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.
Measure Participants	48	47
Mean (Standard Deviation) [Femtoliters]	-0.2 (0.81)	-0.3 (0.63)

45. Secondary Outcome

Title	Part 1: Change From Baseline in Red Blood Cell Count
Description	Blood samples were collected for the assessment of hematology parameters. Change from Baseline in red blood cell count was evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Time Frame	Baseline (Day 1, Pre-dose) and 48 hours post-dose

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	Part 1: Levocetirizine ODT 5 mg	Part 1: Levocetirizine IRT 5 mg
Arm/Group Description	All participants received a single oral dose of levocetirizine ODT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.	All participants received a single oral dose of levocetirizine IRT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.
Measure Participants	24	24
Mean (Standard Deviation) [Trillion cells per liter]	0.078 (0.1189)	0.080 (0.1235)

46. Secondary Outcome

Title	Part 2: Change From Baseline in Red Blood Cell Count
Description	Blood samples were collected for the assessment of hematology parameters. Change from Baseline in red blood cell count was evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Time Frame	Baseline (Day 1, Pre-dose) and 48 hours post-dose

Outcome Measure Data

Analysis Population Description

Safety Population. Only those participants with data available at the specified data points were analyzed.

Arm/Group Title	Part 2: Levocetirizine ODT 5 mg	Part 2: Levocetirizine IRT 5 mg
Arm/Group Description	All participants received a single oral dose of levocetirizine ODT 5 mg tablet without water in fasted state either in Period 1 or Period 2 as per randomization schedule.	All participants received a single oral dose of levocetirizine IRT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.
Measure Participants	48	47
Mean (Standard Deviation) [Trillion cells per liter]	0.040 (0.1730)	0.041 (0.1883)

47. Secondary Outcome

Title	Part 1: Change From Baseline in Reticulocytes
Description	Blood samples were collected for the assessment of hematology parameters. Change from Baseline in reticulocytes was evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Time Frame	Baseline (Day 1, Pre-dose) and 48 hours post-dose

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	Part 1: Levocetirizine ODT 5 mg	Part 1: Levocetirizine IRT 5 mg
Arm/Group Description	All participants received a single oral dose of levocetirizine ODT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.	All participants received a single oral dose of levocetirizine IRT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.
Measure Participants	24	24
Mean (Standard Deviation) [Percentage of reticulocytes]	-0.0001 (0.00167)	0.0004 (0.00186)

48. Secondary Outcome

Title	Part 2: Change From Baseline in Reticulocytes
Description	Blood samples were collected for the assessment of hematology parameters. Change from Baseline in reticulocytes was evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Time Frame	Baseline (Day 1, Pre-dose) and 48 hours post-dose

Outcome Measure Data

Analysis Population Description

Safety Population. Only those participants with data available at the specified data points were analyzed.

Arm/Group Title	Part 2: Levocetirizine ODT 5 mg	Part 2: Levocetirizine IRT 5 mg
Arm/Group Description	All participants received a single oral dose of levocetirizine ODT 5 mg tablet without water in fasted state either in Period 1 or Period 2 as per randomization schedule.	All participants received a single oral dose of levocetirizine IRT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.
Measure Participants	48	47
Mean (Standard Deviation) [Percentage of reticulocytes]	-0.0001 (0.00173)	-0.0004 (0.00169)

49. Secondary Outcome

Title	Part 1: Number of Participants With Urinalysis Results by Dipstick Method
Description	Urine samples were collected to assess urine bilirubin, urine occult blood, urine glucose, urine ketones, urine protein and urine urobilinogen by dipstick test. The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameter of urine bilirubin, urine occult blood, urine glucose, urine ketones, urine protein and urine urobilinogen can be read as negative (-), trace and 1+ indicating proportional concentrations in the urine sample. Only categories with significant values have been presented.
Time Frame	Pre-dose (Day 1) and 48 hours post-dose

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	Part 1: Levocetirizine ODT 5 mg	Part 1: Levocetirizine IRT 5 mg
Arm/Group Description	All participants received a single oral dose of levocetirizine ODT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.	All participants received a single oral dose of levocetirizine IRT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.
Measure Participants	24	24
Bilirubin, Pre-dose, negative	24 200%	24 200%
Bilirubin, 48 hours, negative	24 200%	24 200%
Occult blood, Pre-dose, negative	23 191.7%	24 200%
Occult blood, Pre-dose, trace	1 8.3%	0 0%
Occult blood, 48 hours, negative	23 191.7%	24 200%
Occult blood, 48 hours, trace	1 8.3%	0 0%
Glucose, Pre-dose, negative	24 200%	24 200%
Glucose, 48 hours, negative	24 200%	24 200%
Ketones, Pre-dose, negative	24 200%	23 191.7%
Ketones, Pre-dose, positive (1+)	0 0%	1 8.3%
Ketones, 48 hours, negative	24 200%	24 200%
Protein, Pre-dose, negative	24 200%	24 200%
Protein, 48 hours, negative	24 200%	24 200%
Urobilinogen, Pre-dose, trace	24 200%	24 200%
Urobilinogen, 48 hours, trace	24 200%	24 200%

50. Secondary Outcome

Title	Part 2: Number of Participants With Urinalysis Results by Dipstick Method
Description	Urine samples were collected to assess urine bilirubin, urine occult blood, urine glucose, urine ketones, urine protein and urine urobilinogen by dipstick test. The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameter of urine bilirubin, urine occult blood, urine glucose, urine ketones, urine protein and urine urobilinogen can be read as negative (-), trace and 1+ indicating proportional concentrations in the urine sample. Only categories with significant values have been presented.
Time Frame	Pre-dose (Day 1) and 48 hours post-dose

Outcome Measure Data

Analysis Population Description

Safety Population. Only those participants with data available at the specified data points were analyzed.

Arm/Group Title	Part 2: Levocetirizine ODT 5 mg	Part 2: Levocetirizine IRT 5 mg
Arm/Group Description	All participants received a single oral dose of levocetirizine ODT 5 mg tablet without water in fasted state either in Period 1 or Period 2 as per randomization schedule.	All participants received a single oral dose of levocetirizine IRT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.
Measure Participants	48	47
Bilirubin, Pre-dose, negative	48 400%	47 391.7%
Bilirubin, 48 hours, negative	48 400%	47 391.7%
Occult blood, Pre-dose, negative	48 400%	47 391.7%
Occult blood, 48 hours, negative	47 391.7%	47 391.7%
Occult blood, 48 hours, trace	1 8.3%	0 0%
Glucose, Pre-dose, negative	48 400%	47 391.7%
Glucose, 48 hours, negative	48 400%	47 391.7%
Ketones, Pre-dose, negative	48 400%	46 383.3%
Ketones, Pre-dose, positive (1+)	0 0%	1 8.3%
Ketones, 48 hours, negative	48 400%	47 391.7%
Protein, Pre-dose, negative	48 400%	47 391.7%
Protein, 48 hours, negative	48 400%	47 391.7%
Urobilinogen, Pre-dose, trace	48 400%	47 391.7%
Urobilinogen, 48 hours, trace	48 400%	47 391.7%

51. Secondary Outcome

Title	Part 1: Urine Potential of Hydrogen (pH)
Description	Urine samples were collected for the measurement of urine pH. Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acid pH (5.0 - 6.0).
Time Frame	Pre-dose (Day 1) and 48 hours post-dose

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	Part 1: Levocetirizine ODT 5 mg	Part 1: Levocetirizine IRT 5 mg
Arm/Group Description	All participants received a single oral dose of levocetirizine ODT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.	All participants received a single oral dose of levocetirizine IRT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.
Measure Participants	24	24
Pre-dose	6.04 (0.359)	6.06 (0.340)
48 hours	6.10 (0.329)	6.02 (0.275)

52. Secondary Outcome

Title	Part 2: Urine Potential of Hydrogen (pH)
Description	Urine samples were collected for the measurement of urine pH. Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acid pH (5.0 - 6.0).
Time Frame	Pre-dose (Day 1) and 48 hours post-dose

Outcome Measure Data

Analysis Population Description

Safety Population. Only those participants with data available at the specified data points were analyzed.

Arm/Group Title	Part 2: Levocetirizine ODT 5 mg	Part 2: Levocetirizine IRT 5 mg
Arm/Group Description	All participants received a single oral dose of levocetirizine ODT 5 mg tablet without water in fasted state either in Period 1 or Period 2 as per randomization schedule.	All participants received a single oral dose of levocetirizine IRT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.
Measure Participants	48	47
Pre-dose	6.20 (0.353)	6.11 (0.345)
48 hours	6.09 (0.395)	6.00 (0.376)

53. Secondary Outcome

Title	Part 1: Urine Specific Gravity
Description	Urine samples were collected for the measurement of specific gravity. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. The concentration of the excreted molecules determines the urine's specific gravity. The urinary specific gravity measurement is a routine part of urinalysis. The reference range is 1.002-1.030.
Time Frame	Pre-dose (Day 1) and 48 hours post-dose

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	Part 1: Levocetirizine ODT 5 mg	Part 1: Levocetirizine IRT 5 mg
Arm/Group Description	All participants received a single oral dose of levocetirizine ODT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.	All participants received a single oral dose of levocetirizine IRT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.
Measure Participants	24	24
Pre-dose	1.0158 (0.00724)	1.0144 (0.00658)
48 hours	1.0178 (0.00751)	1.0163 (0.00798)

54. Secondary Outcome

Title	Part 2: Urine Specific Gravity
Description	Urine samples were collected for the measurement of specific gravity. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. The concentration of the excreted molecules determines the urine's specific gravity. The urinary specific gravity measurement is a routine part of urinalysis. The reference range is 1.002-1.030.
Time Frame	Pre-dose (Day 1) and 48 hours post-dose

Outcome Measure Data

Analysis Population Description

Safety Population. Only those participants with data available at the specified data points were analyzed.

Arm/Group Title	Part 2: Levocetirizine ODT 5 mg	Part 2: Levocetirizine IRT 5 mg
Arm/Group Description	All participants received a single oral dose of levocetirizine ODT 5 mg tablet without water in fasted state either in Period 1 or Period 2 as per randomization schedule.	All participants received a single oral dose of levocetirizine IRT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.
Measure Participants	48	47
Pre-dose	1.0156 (0.00646)	1.0179 (0.00666)
48 hours	1.0160 (0.00669)	1.0159 (0.00749)

55. Secondary Outcome

Title	Part 1: Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
Description	Blood pressure was measured in supine position after 5 minutes rest. Change from Baseline in SBP and DBP was evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Time Frame	Baseline (Day 1, Pre-dose) and 1, 24, 48 hours post-dose

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	Part 1: Levocetirizine ODT 5 mg	Part 1: Levocetirizine IRT 5 mg
Arm/Group Description	All participants received a single oral dose of levocetirizine ODT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.	All participants received a single oral dose of levocetirizine IRT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.
Measure Participants	24	24
SBP, 1 hour	-2.0 (9.68)	0.4 (8.54)
SBP, 24 hour	0.0 (7.23)	0.6 (7.20)
SBP, 48 hour	-1.2 (9.64)	1.3 (7.51)
DBP, 1 hour	-1.8 (5.67)	-2.2 (6.84)
DBP, 24 hour	0.3 (4.47)	0.0 (6.19)
DBP, 48 hour	0.6 (6.98)	1.1 (6.10)

56. Secondary Outcome

Title	Part 2: Change From Baseline in SBP and DBP
Description	Blood pressure was measured in supine position after 5 minutes rest. Change from Baseline in SBP and DBP was evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Time Frame	Baseline (Day 1, Pre-dose) and 1, 24, 48 hours post-dose

Outcome Measure Data

Analysis Population Description

Safety Population. Only those participants with data available at the specified data points were analyzed.

Arm/Group Title	Part 2: Levocetirizine ODT 5 mg	Part 2: Levocetirizine IRT 5 mg
Arm/Group Description	All participants received a single oral dose of levocetirizine ODT 5 mg tablet without water in fasted state either in Period 1 or Period 2 as per randomization schedule.	All participants received a single oral dose of levocetirizine IRT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.
Measure Participants	48	47
SBP, 1 hour	0.2 (9.22)	-0.9 (8.27)
SBP, 24 hour	-1.9 (7.69)	-1.2 (9.16)
SBP, 48 hour	0.7 (9.95)	0.3 (9.15)
DBP, 1 hour	-2.6 (7.07)	-2.6 (6.35)
DBP, 24 hour	-2.3 (6.11)	-1.2 (6.23)
DBP, 48 hour	-0.6 (7.15)	-0.2 (6.22)

57. Secondary Outcome

Title	Part 1: Change From Baseline in Heart Rate
Description	Heart rate was measured in supine position after 5 minutes rest. Change from Baseline in heart rate was evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Time Frame	Baseline (Day 1, Pre-dose) and 1, 24, 48 hours post-dose

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	Part 1: Levocetirizine ODT 5 mg	Part 1: Levocetirizine IRT 5 mg
Arm/Group Description	All participants received a single oral dose of levocetirizine ODT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.	All participants received a single oral dose of levocetirizine IRT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.
Measure Participants	24	24
1 hour	-2.3 (4.77)	-0.9 (4.62)
24 hour	-0.8 (5.24)	-0.1 (5.50)
48 hour	0.8 (6.13)	2.5 (5.90)

58. Secondary Outcome

Title	Part 2: Change From Baseline in Heart Rate
Description	Heart rate was measured in supine position after 5 minutes rest. Change from Baseline in heart rate was evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Time Frame	Baseline (Day 1, Pre-dose) and 1, 24, 48 hours post-dose

Outcome Measure Data

Analysis Population Description

Safety Population. Only those participants with data available at the specified data points were analyzed.

Arm/Group Title	Part 2: Levocetirizine ODT 5 mg	Part 2: Levocetirizine IRT 5 mg
Arm/Group Description	All participants received a single oral dose of levocetirizine ODT 5 mg tablet without water in fasted state either in Period 1 or Period 2 as per randomization schedule.	All participants received a single oral dose of levocetirizine IRT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.
Measure Participants	48	47
1 hour	-1.5 (8.34)	-0.6 (5.24)
24 hour	-1.9 (9.16)	0.6 (6.91)
48 hour	1.5 (10.85)	3.0 (9.08)

59. Secondary Outcome

Title	Part 1: Change From Baseline in Body Temperature
Description	Body temperature was measured in supine position after 5 minutes rest. Change from Baseline in body temperature was evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Time Frame	Baseline (Day 1, Pre-dose) and 1, 24, 48 hours post-dose

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	Part 1: Levocetirizine ODT 5 mg	Part 1: Levocetirizine IRT 5 mg
Arm/Group Description	All participants received a single oral dose of levocetirizine ODT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.	All participants received a single oral dose of levocetirizine IRT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.
Measure Participants	24	24
1 hour	0.20 (0.313)	0.02 (0.392)
24 hour	-0.01 (0.292)	0.09 (0.268)
48 hour	0.06 (0.280)	0.01 (0.307)

60. Secondary Outcome

Title	Part 2: Change From Baseline in Body Temperature
Description	Body temperature was measured in supine position after 5 minutes rest. Change from Baseline in body temperature was evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Time Frame	Baseline (Day 1, Pre-dose) and 1, 24, 48 hours post-dose

Outcome Measure Data

Analysis Population Description

Safety Population. Only those participants with data available at the specified data points were analyzed.

Arm/Group Title	Part 2: Levocetirizine ODT 5 mg	Part 2: Levocetirizine IRT 5 mg
Arm/Group Description	All participants received a single oral dose of levocetirizine ODT 5 mg tablet without water in fasted state either in Period 1 or Period 2 as per randomization schedule.	All participants received a single oral dose of levocetirizine IRT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.
Measure Participants	48	47
1 hour	0.19 (0.362)	0.09 (0.359)
24 hour	0.13 (0.272)	0.08 (0.324)
48 hour	0.03 (0.351)	0.03 (0.345)

61. Secondary Outcome

Title	Part 1: Change From Baseline in Heart Rate (12-Lead Electrocardiogram [ECG])
Description	Single 12-lead ECG was obtained using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and QT interval with Fridericia's correction (QTcF). Change from Baseline in heart rate (ECG) was evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Time Frame	Baseline (Day 1, Pre-dose) and 1, 48 hours post-dose

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	Part 1: Levocetirizine ODT 5 mg	Part 1: Levocetirizine IRT 5 mg
Arm/Group Description	All participants received a single oral dose of levocetirizine ODT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.	All participants received a single oral dose of levocetirizine IRT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.
Measure Participants	24	24
1 hour	1.6 (4.80)	1.0 (4.47)
48 hour	2.1 (4.37)	2.5 (4.74)

62. Secondary Outcome

Title	Part 2: Change From Baseline in Heart Rate (ECG)
Description	Single 12-lead ECG was obtained using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and QTcF. Change from Baseline in heart rate (ECG) was evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Time Frame	Baseline (Day 1, Pre-dose) and 1, 48 hours post-dose

Outcome Measure Data

Analysis Population Description

Safety Population. Only those participants with data available at the specified data points were analyzed.

Arm/Group Title	Part 2: Levocetirizine ODT 5 mg	Part 2: Levocetirizine IRT 5 mg
Arm/Group Description	All participants received a single oral dose of levocetirizine ODT 5 mg tablet without water in fasted state either in Period 1 or Period 2 as per randomization schedule.	All participants received a single oral dose of levocetirizine IRT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.
Measure Participants	48	47
1 hour	-1.0 (5.72)	-1.7 (5.83)
48 hour	1.7 (8.22)	1.9 (8.05)

63. Secondary Outcome

Title	Part 1: Change From Baseline in PR Interval, QRS Interval, QT Interval and QTcF Interval
Description	Single 12-lead ECG was obtained using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and QTcF. Change from Baseline in PR interval, QRS interval, QT interval and QTcF interval was evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Time Frame	Baseline (Day 1, Pre-dose) and 1, 48 hours post-dose

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	Part 1: Levocetirizine ODT 5 mg	Part 1: Levocetirizine IRT 5 mg
Arm/Group Description	All participants received a single oral dose of levocetirizine ODT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.	All participants received a single oral dose of levocetirizine IRT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.
Measure Participants	24	24
PR interval, 1 hour	-7.3 (12.16)	-6.3 (10.00)
PR interval, 48 hour	-5.5 (10.72)	-1.9 (13.03)
QRS duration, 1 hour	-0.5 (3.40)	-0.8 (5.24)
QRS duration, 48 hour	1.7 (3.67)	-0.6 (6.37)
QT interval, 1 hour	-9.3 (17.30)	-6.4 (15.38)
QT interval, 48 hour	-14.3 (16.00)	-10.7 (18.17)
QTcF interval, 1 hour	-6.1 (14.06)	-4.3 (11.52)
QTcF interval, 48 hour	-9.3 (14.67)	-4.8 (17.96)

64. Secondary Outcome

Title	Part 2: Change From Baseline in PR Interval, QRS Interval, QT Interval and QTcF Interval
Description	Single 12-lead ECG was obtained using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and QTcF. Change from Baseline in PR interval, QRS interval, QT interval and QTcF interval was evaluated. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Time Frame	Baseline (Day 1, Pre-dose) and 1, 48 hours post-dose

Outcome Measure Data

Analysis Population Description

Safety Population. Only those participants with data available at the specified data points were analyzed.

Arm/Group Title	Part 2: Levocetirizine ODT 5 mg	Part 2: Levocetirizine IRT 5 mg
Arm/Group Description	All participants received a single oral dose of levocetirizine ODT 5 mg tablet without water in fasted state either in Period 1 or Period 2 as per randomization schedule.	All participants received a single oral dose of levocetirizine IRT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.
Measure Participants	48	47
PR interval, 1 hour	-3.2 (11.67)	-2.8 (8.66)
PR interval, 48 hour	1.2 (11.48)	0.6 (9.76)
QRS duration, 1 hour	-1.4 (5.53)	-1.9 (7.99)
QRS duration, 48 hour	0.3 (6.50)	-0.4 (7.17)
QT interval, 1 hour	3.8 (14.45)	3.1 (18.94)
QT interval, 48 hour	-12.1 (17.36)	-11.4 (20.49)
QTcF interval, 1 hour	1.4 (15.35)	-0.9 (17.35)
QTcF interval, 48 hour	-8.5 (15.75)	-7.6 (14.87)

Adverse Events

Time Frame	On-therapy non-SAEs and SAEs were reported from start of study treatment and up to 18 days
Adverse Event Reporting Description	Non-SAE and SAEs were reported for Safety Population. Adverse events were presented treatment-wise.
Arm/Group Title	Part 1: Levocetirizine ODT 5 mg		Part 1: Levocetirizine IRT 5 mg		Part 2: Levocetirizine ODT 5 mg		Part 2: Levocetirizine IRT 5 mg
Arm/Group Description	All participants received a single oral dose of levocetirizine ODT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.		All participants received a single oral dose of levocetirizine IRT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.		All participants received a single oral dose of levocetirizine ODT 5 mg tablet without water in fasted state either in Period 1 or Period 2 as per randomization schedule.		All participants received a single oral dose of levocetirizine IRT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.
All Cause Mortality
	Part 1: Levocetirizine ODT 5 mg		Part 1: Levocetirizine IRT 5 mg		Part 2: Levocetirizine ODT 5 mg		Part 2: Levocetirizine IRT 5 mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/24 (0%)		0/24 (0%)		0/48 (0%)		0/48 (0%)
Serious Adverse Events
	Part 1: Levocetirizine ODT 5 mg		Part 1: Levocetirizine IRT 5 mg		Part 2: Levocetirizine ODT 5 mg		Part 2: Levocetirizine IRT 5 mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/24 (0%)		0/24 (0%)		0/48 (0%)		0/48 (0%)
Other (Not Including Serious) Adverse Events
	Part 1: Levocetirizine ODT 5 mg		Part 1: Levocetirizine IRT 5 mg		Part 2: Levocetirizine ODT 5 mg		Part 2: Levocetirizine IRT 5 mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/24 (0%)		0/24 (0%)		6/48 (12.5%)		0/48 (0%)
Gastrointestinal disorders
Diarrhoea	0/24 (0%)		0/24 (0%)		1/48 (2.1%)		0/48 (0%)
Infections and infestations
Nasopharyngitis	0/24 (0%)		0/24 (0%)		2/48 (4.2%)		0/48 (0%)
Tonsillitis	0/24 (0%)		0/24 (0%)		1/48 (2.1%)		0/48 (0%)
Investigations
Alanine aminotransferase increased	0/24 (0%)		0/24 (0%)		1/48 (2.1%)		0/48 (0%)
Aspartate aminotransferase increased	0/24 (0%)		0/24 (0%)		1/48 (2.1%)		0/48 (0%)
Musculoskeletal and connective tissue disorders
Neck pain	0/24 (0%)		0/24 (0%)		1/48 (2.1%)		0/48 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.