Bioequivalence Study of Paroxetine Immediate Release (IR) Tablets Manufactured in GlaxoSmithKline Tianjin (GSKT) and Mississauga Sites in Healthy Chinese Subjects

• Sponsor: GlaxoSmithKline (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03329573
• Collaborator: (none)
• Enrollment: 85
• Location: 1
• Arms: 4
• Actual Duration (Months): 2.1
• Patients Per Site Per Month: 39.8

Study Details

Study Description

Brief Summary

Paroxetine is a selective serotonin reuptake inhibitor (SSRI) and paroxetine IR tablets have been approved for the treatment of three anxiety indications in China. This bioequivalence study will evaluate Paroxetine IR tablets manufactured in GSKT (A) and Mississauga (B) sites in healthy Chinese subjects under fasting and fed conditions to support the quality consistency evaluation. This is a single dose, open-label, randomized, two-period crossover study and will include a screening period (up to 7 days), two open-label treatment periods (up to 16 days) and a follow-up phase (up to 14 days after last-dose). The whole study will be divided into two groups, one for fasting condition enrolling approximately 36 subjects and another for fed condition for which approximately 44 subjects will be enrolled. In both groups, eligible subjects will be randomized to receive single dose of Paroxetine IR tablets A or B in a cross-over manner.

Condition or Disease	Intervention/Treatment	Phase
Anxiety Disorders	Drug: Paroxetine IR tablets A; Drug: Paroxetine IR tablets B	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 85 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Intervention Model Description: In this study, each subject will receive paroxetine IR 40mg A or B in a cross-over mannerIn this study, each subject will receive paroxetine IR 40mg A or B in a cross-over manner
• Masking: None (Open Label)
• Masking Description: This study is an open-label treatment period; hence, masking will not be performed.
• Primary Purpose: Treatment
• Official Title: Randomized, Open Label, 2-way Crossover, Single Dose Bioequivalence Study of Paroxetine IR Tablets Manufactured in GSKT and Mississauga Sites in Healthy Chinese Participants Under Fasting and Fed Conditions
• Actual Study Start Date: May 30, 2018
• Actual Primary Completion Date: Aug 3, 2018
• Actual Study Completion Date: Aug 3, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: AB treatment sequence receivers in fasting group Eligible subjects will receive a single dose of Paroxetine IR tablets A in Period 1 followed by Paroxetine IR tablets B in Period 2 in fasting state.	Drug: Paroxetine IR tablets A; Paroxetine IR tablets A will be the investigational drug. These are film coated tablets with unit dose strength of 20 milligrams (mg) and will be administered via oral route. These tablets will be manufactured in GSKT.; Drug: Paroxetine IR tablets B; Paroxetine IR tablets B will be the reference drug. These are film coated tablets with unit dose strength of 20 mg and will be administered via oral route. These tablets will be manufactured in Mississauga.
Experimental: BA treatment sequence receivers in fasting group Eligible subjects will receive a single dose of Paroxetine IR tablets B in Period 1 followed by Paroxetine IR tablets A in Period 2 in fasting state.	Drug: Paroxetine IR tablets A; Paroxetine IR tablets A will be the investigational drug. These are film coated tablets with unit dose strength of 20 milligrams (mg) and will be administered via oral route. These tablets will be manufactured in GSKT.; Drug: Paroxetine IR tablets B; Paroxetine IR tablets B will be the reference drug. These are film coated tablets with unit dose strength of 20 mg and will be administered via oral route. These tablets will be manufactured in Mississauga.
Experimental: AB treatment sequence receivers in fed group Eligible subjects will receive a single dose of Paroxetine IR tablets A in Period 1 followed by Paroxetine IR tablets B in Period 2 in fed state.	Drug: Paroxetine IR tablets A; Paroxetine IR tablets A will be the investigational drug. These are film coated tablets with unit dose strength of 20 milligrams (mg) and will be administered via oral route. These tablets will be manufactured in GSKT.; Drug: Paroxetine IR tablets B; Paroxetine IR tablets B will be the reference drug. These are film coated tablets with unit dose strength of 20 mg and will be administered via oral route. These tablets will be manufactured in Mississauga.
Experimental: BA treatment sequence receivers in fed group Eligible subjects will receive a single dose of Paroxetine IR tablets B in Period 1 followed by Paroxetine IR tablets A in Period 2 in fed state.	Drug: Paroxetine IR tablets A; Paroxetine IR tablets A will be the investigational drug. These are film coated tablets with unit dose strength of 20 milligrams (mg) and will be administered via oral route. These tablets will be manufactured in GSKT.; Drug: Paroxetine IR tablets B; Paroxetine IR tablets B will be the reference drug. These are film coated tablets with unit dose strength of 20 mg and will be administered via oral route. These tablets will be manufactured in Mississauga.

Outcome Measures

Primary Outcome Measures

1. Area Under the Concentration-time Curve From Time Zero Extrapolated to Infinite Time (AUC[0-infinity]) of Paroxetine Following Single Oral Dose in Healthy Chinese Participants Under Fed Condition [Pre-dose, 0.5 hour, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 7 hours, 8 hours, 10 hours, 12 hours, 16 hours, 24 hours, 36 hours, 48 hours, 72 hours and 96 hours post-dose in each treatment period]

   Blood samples were collected at designated time points. Pharmacokinetic (PK) parameters of Paroxetine were calculated using non-compartmental methods. Statistical analysis of PK parameters was done using mixed effect model for evaluation of bioequivalence (BE). Point estimate and associated adjusted 90% confidence interval (CI) of difference between both the treatments were provided for AUC(0-infinity).

2. AUC(0-infinity) of Paroxetine Following Single Oral Dose in Healthy Chinese Participants Under Fasting Condition [Pre-dose, 0.5 hour, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 7 hours, 8 hours, 10 hours, 12 hours, 16 hours, 24 hours, 36 hours, 48 hours, 72 hours and 96 hours post-dose in each treatment period]

   Blood samples were collected at designated timepoints. PK parameters of Paroxetine were calculated using non-compartmental methods. Statistical analysis of PK parameters was done using mixed effect model for evaluation of BE. Point estimate and associated adjusted 90% CI of difference between both the treatments were provided for AUC(0-infinity).

3. Area Under the Concentration-time Curve From Administration Extrapolated to the Last Time of Quantifiable Concentration (AUC[0-t]) of Paroxetine Following Single Oral Dose in Healthy Chinese Participants Under Fed Condition [Pre-dose, 0.5 hour, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 7 hours, 8 hours, 10 hours, 12 hours, 16 hours, 24 hours, 36 hours, 48 hours, 72 hours and 96 hours post-dose in each treatment period]

   Blood samples were collected at designated timepoints. PK parameters of Paroxetine were calculated using non-compartmental methods. Statistical analysis of PK parameters was done using mixed effect model for evaluation of BE. Point estimate and associated adjusted 90% CI of difference between both the treatments were provided for AUC(0-t).

4. AUC(0-t) of Paroxetine Following Single Oral Dose in Healthy Chinese Participants Under Fasting Condition [Pre-dose, 0.5 hour, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 7 hours, 8 hours, 10 hours, 12 hours, 16 hours, 24 hours, 36 hours, 48 hours, 72 hours and 96 hours post-dose in each treatment period]

   Blood samples were collected at designated timepoints. PK parameters of Paroxetine were calculated using non-compartmental methods. Statistical analysis of PK parameters was done using mixed effect model for evaluation of BE. Point estimate and associated adjusted 90% CI of difference between both the treatments were provided for AUC(0-t).

5. Maximum Observed Concentration (Cmax) of Paroxetine Following Single Oral Dose in Healthy Chinese Participants Under Fed Condition [Pre-dose, 0.5 hour, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 7 hours, 8 hours, 10 hours, 12 hours, 16 hours, 24 hours, 36 hours, 48 hours, 72 hours and 96 hours post-dose in each treatment period]

   Blood samples were collected at designated timepoints. PK parameters of Paroxetine were calculated using non-compartmental methods. Statistical analysis of PK parameters was done using mixed effect model for evaluation of BE. Point estimate and associated adjusted 90% CI of difference between both the treatments were provided for Cmax.

6. Cmax of Paroxetine Following Single Oral Dose in Healthy Chinese Participants Under Fasting Condition [Pre-dose, 0.5 hour, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 7 hours, 8 hours, 10 hours, 12 hours, 16 hours, 24 hours, 36 hours, 48 hours, 72 hours and 96 hours post-dose in each treatment period]

   Blood samples were collected at designated timepoints. PK parameters of Paroxetine were calculated using non-compartmental methods. Statistical analysis of PK parameters was done using mixed effect model for evaluation of BE. Point estimate and associated adjusted 90% CI of difference between both the treatments were provided for Cmax.

Secondary Outcome Measures

1. Time to Reach Maximum Observed Concentration (Tmax) of Paroxetine Following Single Oral Dose in Healthy Chinese Participants Under Fed Condition [Pre-dose, 0.5 hour, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 7 hours, 8 hours, 10 hours, 12 hours, 16 hours, 24 hours, 36 hours, 48 hours, 72 hours and 96 hours post-dose in each treatment period]

   Blood samples were collected at designated timepoints. PK parameters of Paroxetine were calculated using non-compartmental methods. Median and full range of Tmax have been presented.

2. Tmax of Paroxetine Following Single Oral Dose in Healthy Chinese Participants Under Fasting Condition [Pre-dose, 0.5 hour, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 7 hours, 8 hours, 10 hours, 12 hours, 16 hours, 24 hours, 36 hours, 48 hours, 72 hours and 96 hours post-dose in each treatment period]

   Blood samples were collected at designated timepoints. PK parameters of Paroxetine were calculated using non-compartmental methods. Median and full range of Tmax have been presented.

3. Terminal Elimination Rate Constant (Lambda z) of Paroxetine Following Single Oral Dose in Healthy Chinese Participants Under Fed Condition [Pre-dose, 0.5 hour, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 7 hours, 8 hours, 10 hours, 12 hours, 16 hours, 24 hours, 36 hours, 48 hours, 72 hours and 96 hours post-dose in each treatment period]

   Blood samples were collected at designated timepoints. PK parameters of Paroxetine were calculated using non-compartmental methods. Geometric mean and 95% CI of Lambda z have been presented.

4. Lambda z of Paroxetine Following Single Oral Dose in Healthy Chinese Participants Under Fasting Condition [Pre-dose, 0.5 hour, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 7 hours, 8 hours, 10 hours, 12 hours, 16 hours, 24 hours, 36 hours, 48 hours, 72 hours and 96 hours post-dose in each treatment period]

   Blood samples were collected at designated timepoints. PK parameters of Paroxetine were calculated using non-compartmental methods. Geometric mean and 95% CI of Lambda z have been presented.

5. Terminal Elimination Half-life (t1/2) of Paroxetine Following Single Oral Dose in Healthy Chinese Participants Under Fed Condition [Pre-dose, 0.5 hour, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 7 hours, 8 hours, 10 hours, 12 hours, 16 hours, 24 hours, 36 hours, 48 hours, 72 hours and 96 hours post-dose in each treatment period]

   Blood samples were collected at designated timepoints. PK parameters of Paroxetine were calculated using non-compartmental methods. Geometric mean and 95% CI have been presented.

6. t1/2 of Paroxetine Following Single Oral Dose in Healthy Chinese Participants Under Fasting Condition [Pre-dose, 0.5 hour, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 7 hours, 8 hours, 10 hours, 12 hours, 16 hours, 24 hours, 36 hours, 48 hours, 72 hours and 96 hours post-dose in each treatment period]

   Blood samples were collected at designated timepoints. PK parameters of Paroxetine were calculated using non-compartmental methods. Geometric mean and 95% CI have been presented.

7. Number of Participants With Non-serious Adverse Events and Serious Adverse Events (SAEs) Under Fed Condition [Up to Day 26]

   An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect and other situations according to medical or scientific judgement or events associated with liver injury and impaired liver function. Data has been presented treatment-wise.

8. Number of Participants With Non-SAE and SAEs Under Fasting Condition [Up to Day 26]

   An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect and other situations according to medical or scientific judgement or events associated with liver injury and impaired liver function. Data has been presented treatment-wise.

9. Number of Participants With Chemistry Laboratory Values Relative to Potential Clinical Importance (PCI) Criteria on Day 16 Under Fed Condition [Day 16]

   Blood samples were collected to analyze the clinical chemistry laboratory parameters; alanine aminotransferase (ALT), albumin, alkaline phosphatase (ALP), aspartate aminotransferase (AST),calcium,creatinine, glucose, potassium (Pot) and sodium. PCI ranges were ALT (high: >=2 times upper limit of normal [ULN] units per liter [U/L]),albumin (low: <30 grams per liter),ALP (low: <20 international units per liter [IU/L] and high: >200 IU/L), AST (high: >=2 times ULN U/L),calcium (low: <2 millimoles per liter [mmol/L] and high: >2.75 mmol/L),creatinine (high: >133 micromoles per liter), glucose (low: <3 mmol/L and high: >9 mmol/L), Pot (low: <3 mmol/L and high: >5.5 mmol/L) and sodium (low: <130 mmol/L and high: >150 mmol/L). Participants were counted in the category that their value changed to (low, normal or high). If values were unchanged (example: High to High), or whose value became normal, were recorded in the 'To Normal or No Change' category. Data has been presented treatment-wise.

10. Number of Participants With Chemistry Laboratory Values Relative to PCI Criteria on Day 16 Under Fasting Condition [Day 16]

    Blood samples were collected to analyze the clinical chemistry laboratory parameters; ALT, albumin, ALP, AST, calcium, creatinine, glucose, Pot and sodium. PCI ranges were ALT (high: >=2 times ULN U/L), albumin (low: <30 grams per liter), ALP (low: <20 IU/L and high: >200 IU/L), AST (high: >=2 times ULN U/L), calcium (low: <2 mmol/L and high: >2.75 mmol/L), creatinine (high: >133 micromoles per liter), glucose (low: <3 mmol/L and high: >9 mmol/L), Pot (low: <3 mmol/L and high: >5.5 mmol/L) and sodium (low: <130 mmol/L and high: >150 mmol/L). Participants were counted in the category that their value changed to (low, normal or high). If values were unchanged (example: High to High), or whose value became normal, were recorded in the 'To Normal or No Change' category. Data has been presented treatment-wise.

11. Number of Participants With Hematology Laboratory Values Relative to PCI Criteria on Day 16 Under Fed Condition [Day 16]

    Blood samples were collected to analyze; hematocrit(Hct),hemoglobin(Hb),erythrocytes and platelets. PCI ranges; Hct(Male[low: <0.03 proportion of red blood cells in blood and high: >0.54 proportion of red blood cells in blood] and Female[low: <0.04 proportion of red blood cells in blood and high: >0.54 proportion of red blood cells in blood]),Hb(Male [low: <110 grams per liter and high: >180 grams per liter) and Female[low: <100 grams per liter and high: >170 grams per liter]),erythrocytes(Male [low: <4.5x10^12 cells per liter and high: >5.5x10^12 cells per liter] and Female[low: <4 x10^12 cells per liter and high: >5 x10^12 cells per liter]) and platelets(low: <80x10^9 cells per liter and high: >400x10^9 cells per liter). Participants were counted in the category that their value changed to(low, normal or high). If values were unchanged(example: High to High), or whose value became normal, were recorded in the 'To Normal or No Change' category.Data has been presented treatment-wise.

12. Number of Participants With Hematology Laboratory Values Relative to PCI Criteria on Day 16 Under Fasting Condition [Day 16]

    Blood samples were collected to analyze; Hct, Hb, erythrocytes and platelets. PCI ranges were Hct (Male [low: <0.03 proportion of red blood cells in blood and high: >0.54 proportion of red blood cells in blood] and Female [low: <0.04 proportion of red blood cells in blood and high: >0.54 proportion of red blood cells in blood]), Hb (Male [low: <110 grams per liter and high: >180 grams per liter) and Female [low: <100 grams per liter and high: >170 grams per liter]), erythrocytes (Male [low: <4.5x10^12 cells per liter and high: >5.5x10^12 cells per liter] and Female [low: <4 x10^12 cells per liter and high: >5 x10^12 cells per liter]) and platelets (low: <80x10^9 cells per liter and high: >400x10^9 cells per liter). Participants were counted in the category that their value changed to (low, normal or high). If values were unchanged (example: High to High), or whose value became normal, were recorded in the 'To Normal or No Change' category. Data has been presented treatment-wise.

13. Number of Participants With Urinalysis Results by Dipstick Method Under Fed Condition [Baseline (Day-7 to Day -1) and Day 16]

    Urine samples were collected to assess urine occult blood, urine glucose, urine ketones, urine protein and monitor urine potential of hydrogen (pH). The dipstick test gave results in a semi-quantitative manner, and results for urinalysis parameters (except urine pH) were recorded as negative and positive, indicating proportional concentrations in the urine sample. pH is a measure of hydrogen ion concentration and is used to determine the acidity or alkalinity of urine. Urine pH is calculated on a scale of 0 to 14, values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH of less than 7 is acidic and a pH of greater than 7 is basic. Normal urine has a slightly acidic pH (5.0-6.0). Dipstick test results for pH were presented as number of participants having pH value as 5, 6, 6.5, 7 or 8. Data has been presented treatment-wise.

14. Number of Participants With Urinalysis Results by Dipstick Method Under Fasting Condition [Baseline (Day-7 to Day -1) and Day 16]

    Urine samples were collected to assess urine occult blood, urine glucose, urine ketones, urine protein and monitor urine pH. The dipstick test gave results in a semi-quantitative manner, and results for urinalysis parameters (except urine pH) were recorded as negative and positive, indicating proportional concentrations in the urine sample. pH is a measure of hydrogen ion concentration and is used to determine the acidity or alkalinity of urine. Urine pH is calculated on a scale of 0 to 14, values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH of less than 7 is acidic and a pH of greater than 7 is basic. Normal urine has a slightly acidic pH (5.0-6.0). Dipstick test results for pH were presented as number of participants having pH value as 5, 6, 6.5, 7 or 8. Data has been presented treatment-wise.

15. Number of Participants With Clinically Significant Abnormal Findings for Electrocardiogram (ECG) Parameters Under Fed Condition [Baseline (Day-7 to Day -1) and Day 16]

    A single 12-lead ECGs was obtained using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT and QT corrected (QTc) intervals. Clinically significant abnormal ranges were: heart rate: lower:<50 beats per minute and upper: >110 beats per minute; QT: Upper: >400 milliseconds (msec); QTc: Upper: >450 msec; PR: lower: <110 msec and upper: >220 msec; QRS: lower: <60 msec and upper: >120 msec. The number of participants with abnormal findings for ECG parameters have been presented. Data has been presented treatment-wise.

16. Number of Participants With Clinically Significant Abnormal Findings for ECG Parameters Under Fasting Condition [Baseline (Day-7 to Day -1) and Day 16]

    A single 12-lead ECGs was obtained using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT and QTc intervals. Clinically significant abnormal ranges were: heart rate: lower :<50 beats per minute and upper: >110 beats per minute; QT: Upper: >400 msec; QTc: Upper: >450 msec; PR: lower: <110 msec and upper: >220 msec; QRS: lower: <60 msec and upper: >120 msec. The number of participants with abnormal findings for ECG parameters have been presented. Data has been presented treatment-wise.

17. Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) at Indicated Time-points Under Fed Condition [Day 1 (post-dose), Day 2 (post-dose), Day 3, Day 4, Day 5, Day 11, Day 12 (pre-dose), Day 12 (post-dose), Day 13 (post-dose), Day 14, Day 15, Day 16]

    Vital signs including DBP and SBP were measured at the indicated time-points and summarized during the study to evaluate the safety of the participants. Data has been presented treatment-wise.

18. DBP and SBP at Indicated Time-points Under Fasting Condition [Day 1 (post-dose), Day 2 (post-dose), Day 3, Day 4, Day 5, Day 11, Day 12 (pre-dose), Day 12 (post-dose), Day 13 (post-dose), Day 14, Day 15, Day 16]

    Vital signs including DBP and SBP were measured at the indicated time-points and summarized during the study to evaluate the safety of the participants. Data has been presented treatment-wise.

19. Pulse Rate (PR) at Indicated Time-points Under Fed Condition [Day 1 (post-dose), Day 2 (post-dose), Day 3, Day 4, Day 5, Day 11, Day 12 (pre-dose), Day 12 (post-dose), Day 13 (post-dose), Day 14, Day 15, Day 16]

    Vital sign including PR was measured at the indicated time-points and summarized during the study to evaluate the safety of the participants. Data has been presented treatment-wise.

20. Pulse Rate (PR) at Indicated Time-points Under Fasting Condition [Day 1 (post-dose), Day 2 (post-dose), Day 3, Day 4, Day 5, Day 11, Day 12 (pre-dose), Day 12 (post-dose), Day 13 (post-dose), Day 14, Day 15, Day 16]

    Vital sign including PR was measured at the indicated time-points and summarized during the study to evaluate the safety of the participants. Data has been presented treatment-wise.

21. Respiratory Rate (RR) at Indicated Time-point Under Fed Condition [Day 11]

    Vital sign including RR was measured at the indicated time-point and summarized during the study to evaluate the safety of the participants. Data has been presented treatment-wise.

22. RR at Indicated Time-point Under Fasting Condition [Day 11]

    Vital sign including RR was measured at the indicated time-point and summarized during the study to evaluate the safety of the participants. Data has been presented treatment-wise.

23. Temperature at Indicated Time-point Under Fed Condition [Day 11]

    Vital sign including temperature was measured at the indicated time-point and summarized during the study to evaluate the safety of the participants. Data has been presented treatment-wise.

24. Temperature at Indicated Time-point Under Fasting Condition [Day 11]

    Vital sign including temperature was measured at the indicated time-point and summarized during the study to evaluate the safety of the participants. Data has been presented treatment-wise.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Able to actively communicate with the investigator and to complete the study-related documents; able to understand the contents of the Informed consent form (ICF) and to sign a written ICF prior to any study-specific procedures.

• Males and females aged between 18 and 45 years inclusive, at the time of signing the informed consent.

• Non-smoking healthy males and females as assessed by medical history and physical examination. Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring. A subject with a clinical abnormality or laboratory parameters which are not specifically listed in the inclusion or exclusion criteria, outside the reference range for the population being studied may be included only if the Investigator (in consultation with the GSK Medical Monitor if necessary) agree and document that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures.

• Body weight>=50 kilograms (kg) (male) or 45kg(female) and Body mass index (BMI) 19.0 to 26.0 kg per meter square (kg/m^2) (inclusive).

• A female subject is eligible to participate if she is of: Child-bearing potential with negative pregnancy test as determined by serum or urine human chorionic gonadotropin (hCG) test at screening or prior to dosing and agrees to use the one of the defined contraception method during the study and until follow up contact.

• Male Subjects with female partners of child-bearing potential must agree to use one of the defined contraception methods during the study and until follow up contact.

• ALT, ALP and total bilirubin <=1.5x upper limit of normal (ULN) (isolated bilirubin

1.5x ULN is acceptable if bilirubin is fractionated and direct bilirubin <35 percent).

• Based on single or averaged corrected QT interval (QTc) values of triplicate ECGs obtained over a brief recording period: QTc < 450 milliseconds (msec); or QTc < 480 msec in subjects with bundlebranch block.

Exclusion Criteria:

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

• Drug or alcohol abuse or dependency within one year prior to enrolment. History of regular alcohol consumption within one year of the study defined as: an average weekly intake of >14 drinks. One drink is equivalent to 12 grams (g) of alcohol: 12 ounces [360 milliliter (mL)] of beer, 5 ounces (150 mL) of wine or 1.5 ounces (45 mL) of 80 proof distilled spirits.

• Unstable disease conditions; any laboratory measurements assessed by the investigator as clinically relevant (including ECG, hematology, biochemistry and urine analysis, etc.)；any disorder that might interfere with the absorption, distribution, metabolism or excretion of the study drug; or in the investigator's opinion the disease may lead to safety concerns or interfere with the pharmacokinetics assessment.

• Subjects with concurrent or previous neuropsychological disorders, as assessed by Columbia Suicide Severity Rating Scale or by the investigator, have suicidal tendency, or have committed suicidal behavior/attempt.

• Known history of cerebral trauma, previous cerebral disorders, seizures or eating disorder, and other conditions that in the investigator's opinion may increase the risk of seizures.

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

• Unable to refrain from the use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John's Wort) within 14 days or 5 half-lives (whichever is longer) prior to the first dose of study medication.

• In subjects with concomitant use of monoamine oxidase inhibitors (MAOIs) (including linezolid, an antibiotic which is a reversible non-selective MAOIs and methylthioninium chloride (methylene blue)) or within two weeks of terminating treatment with MAOIs.

• In subjects with concomitant use of thioridazine or pimozide.

• The subject has participated in a clinical trial and has received an investigational product within 90 days prior to the first dosing day in the current study, or has participated in a clinical trial without receiving any investigational product within 30 days prior to the first dosing day in the current study.

• A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months.

• Serum human immuno-deficiency virus (HIV) antibody or Syphilis antibody positive.

• A positive pre-study drug/alcohol screen.

• Known allergy to paroxetine IR Tablets or any of its components.

• Blood donation in excess of 400 mL in the 3 months prior to enrolment.

• Obvious evidence of active hematological diseases, or significant blood loss in the last 3 months. History of sensitivity to heparin or heparin-induced thrombocytopenia.

• Lactating females or women of child bearing potential used oral or implanted contraceptives within the 30 days prior to enrolment, or received injections of chronically acting contraceptives in the 1 year prior to study initiation.

• Other conditions which, in the Investigator's judgment, render subjects unsuitable for the clinical study.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	GSK Investigational Site	Shanghai		China	201508

Sponsors and Collaborators

• GlaxoSmithKline

Investigators

• Study Director: GSK Clinical Trials, GlaxoSmithKline

Study Documents (Full-Text)

• Statistical Analysis Plan - Sep 6, 2018
• Study Protocol - Jul 20, 2018

More Information

Publications

None provided.

• Responsible Party: GlaxoSmithKline
• ClinicalTrials.gov Identifier: NCT03329573
• Other Study ID Numbers: 207652
• First Posted: Nov 6, 2017
• Last Update Posted: Mar 27, 2020
• Last Verified: Mar 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: Cross-over; Chinese; GSKT; Mississauga; Healthy; Bioequivalence; Paroxetine
• Additional relevant MeSH terms: Anxiety Disorders; Paroxetine

Study Results

Participant Flow

Recruitment Details	This was a single dose, open-label, randomized, two-period crossover study to demonstrate the bioequivalence of Paroxetine immediate release (IR) tablets manufactured in GlaxoSmithKline Tianjin (GSKT) (A) and Mississauga (B) sites in healthy Chinese participants under fasting and fed conditions.
Pre-assignment Detail	Participants received treatment in one of the two sequences; treatment A (GSKT, Paroxetine IR investigational drug) followed by treatment B (Mississauga, Paroxetine IR reference drug) or vice versa in each of the treatment period 1 and 2. A total of 85 (47 under fed condition and 38 under fasting condition) participants were enrolled.

Arm/Group Title	Paroxetine 40 mg, GSKT Followed by Mississauga- Fed	Paroxetine 40 mg, Mississauga Followed by GSKT- Fed	Paroxetine 40 mg, GSKT Followed by Mississauga- Fasted	Paroxetine 40 mg, Mississauga Followed by GSKT- Fasted
Arm/Group Description	Eligible participants received a single dose of treatment A: GSKT, Paroxetine IR 40 milligrams (mg) (20 mg*2 tablets) administered orally on Day 1 in treatment period 1. It was followed by a washout period from Day 6 to Day 11. Participants received treatment B: Mississauga, Paroxetine IR 40 mg (20 mg*2 tablets) administered orally on Day 12 in treatment period 2. All these doses were administered under fed condition.	Eligible participants received a single dose of treatment B: Mississauga, Paroxetine IR 40 mg (20 mg*2 tablets) administered orally on Day 1 in treatment period 1. It was followed by a washout period from Day 6 to Day 11. Participants received treatment A: GSKT, Paroxetine IR 40 mg (20 mg*2 tablets) administered orally on Day 12 in treatment period 2. All these doses were administered under fed condition.	Eligible participants received a single dose of treatment A: GSKT, Paroxetine IR 40 milligrams (mg) (20 mg*2 tablets) administered orally on Day 1 in treatment period 1. It was followed by a washout period from Day 6 to Day 11. Participants received treatment B: Mississauga, Paroxetine IR 40 mg (20 mg*2 tablets) administered orally on Day 12 in treatment period 2. All these doses were administered under fasting condition.	Eligible participants received a single dose of treatment B: Mississauga, Paroxetine IR 40 mg (20 mg*2 tablets) administered orally on Day 1 in treatment period 1. It was followed by a washout period from Day 6 to Day 11. Participants received treatment A: GSKT, Paroxetine IR 40 mg (20 mg*2 tablets) administered orally on Day 12 in treatment period 2. All these doses were administered under fasting condition.
Period Title: Treatment Period 1 (Up to 5 Days)
STARTED	23	24	19	19
COMPLETED	22	21	19	19
NOT COMPLETED	1	3	0	0
Period Title: Treatment Period 1 (Up to 5 Days)
STARTED	22	21	19	19
COMPLETED	22	21	19	19
NOT COMPLETED	0	0	0	0
Period Title: Treatment Period 1 (Up to 5 Days)
STARTED	22	21	19	19
COMPLETED	21	20	19	19
NOT COMPLETED	1	1	0	0

Baseline Characteristics

Arm/Group Title	Paroxetine 40 mg, GSKT Followed by Mississauga- Fed	Paroxetine 40 mg, Mississauga Followed by GSKT- Fed	Paroxetine 40 mg, GSKT Followed by Mississauga- Fasted	Paroxetine 40 mg, Mississauga Followed by GSKT- Fasted	Total
Arm/Group Description	Eligible participants received a single dose of treatment A: GSKT, Paroxetine IR 40 milligrams (mg) (20 mg*2 tablets) administered orally on Day 1 in treatment period 1. It was followed by a washout period from Day 6 to Day 11. Participants received treatment B: Mississauga, Paroxetine IR 40 mg (20 mg*2 tablets) administered orally on Day 12 in treatment period 2. All these doses were administered under fed condition.	Eligible participants received a single dose of treatment B: Mississauga, Paroxetine IR 40 mg (20 mg*2 tablets) administered orally on Day 1 in treatment period 1. It was followed by a washout period from Day 6 to Day 11. Participants received treatment A: GSKT, Paroxetine IR 40 mg (20 mg*2 tablets) administered orally on Day 12 in treatment period 2. All these doses were administered under fed condition.	Eligible participants received a single dose of treatment A: GSKT, Paroxetine IR 40 milligrams (mg) (20 mg*2 tablets) administered orally on Day 1 in treatment period 1. It was followed by a washout period from Day 6 to Day 11. Participants received treatment B: Mississauga, Paroxetine IR 40 mg (20 mg*2 tablets) administered orally on Day 12 in treatment period 2. All these doses were administered under fasting condition.	Eligible participants received a single dose of treatment B: Mississauga, Paroxetine IR 40 mg (20 mg*2 tablets) administered orally on Day 1 in treatment period 1. It was followed by a washout period from Day 6 to Day 11. Participants received treatment A: GSKT, Paroxetine IR 40 mg (20 mg*2 tablets) administered orally on Day 12 in treatment period 2. All these doses were administered under fasting condition.	Total of all reporting groups
Overall Participants	23	24	19	19	85
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	30.3 (7.53)	27.1 (5.63)	25.4 (5.86)	28.1 (6.17)	27.3 (6.46)
Sex: Female, Male (Count of Participants)
Female	11 47.8%	10 41.7%	9 47.4%	10 52.6%	40 47.1%
Male	12 52.2%	14 58.3%	10 52.6%	9 47.4%	45 52.9%
Race/Ethnicity, Customized (Count of Participants)
Asian - East Asian Heritage	23 100%	24 100%	19 100%	19 100%	85 100%

Outcome Measures

1. Primary Outcome

Title	Area Under the Concentration-time Curve From Time Zero Extrapolated to Infinite Time (AUC[0-infinity]) of Paroxetine Following Single Oral Dose in Healthy Chinese Participants Under Fed Condition
Description	Blood samples were collected at designated time points. Pharmacokinetic (PK) parameters of Paroxetine were calculated using non-compartmental methods. Statistical analysis of PK parameters was done using mixed effect model for evaluation of bioequivalence (BE). Point estimate and associated adjusted 90% confidence interval (CI) of difference between both the treatments were provided for AUC(0-infinity).
Time Frame	Pre-dose, 0.5 hour, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 7 hours, 8 hours, 10 hours, 12 hours, 16 hours, 24 hours, 36 hours, 48 hours, 72 hours and 96 hours post-dose in each treatment period

Outcome Measure Data

Analysis Population Description

BE analysis Population. BE analysis Population comprised of all randomized participants who completed all the planned treatments and provided at least one evaluable primary PK parameter data from both period 1 and period 2. Only those participants with data available at the specified data points were analyzed.

Arm/Group Title	Paroxetine 40 mg, GSKT- Fed	Paroxetine 40 mg, Mississauga- Fed
Arm/Group Description	Eligible participants received a single dose of treatment A: GSKT, Paroxetine IR 40 mg (20 mg*2 tablets) administered orally on Day 1 in either treatment period 1 or 2 as per randomization under fed condition.	Eligible participants received a single dose of treatment B: Mississauga, Paroxetine IR 40 mg (20 mg*2 tablets) administered orally on Day 1 in either treatment period 1 or 2 as per randomization under fed condition.
Measure Participants	40	40
Geometric Mean (90% Confidence Interval) [Hour*nanogram per milliliter]	860.54	812.49

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Paroxetine 40 mg, GSKT- Fed, Paroxetine 40 mg, Mississauga- Fed
	Comments
	Type of Statistical Test	Equivalence
	Comments	The two formulations were considered to be bioequivalent if the 90% confidence interval of AUC(0-infinity) for difference between both treatments fall in the range of 0.80-1.25.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Ratio of Geometrical Mean
	Estimated Value	1.059
	Confidence Interval	(2-Sided) 90%; 1.006 to 1.115
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Primary Outcome

Title	AUC(0-infinity) of Paroxetine Following Single Oral Dose in Healthy Chinese Participants Under Fasting Condition
Description	Blood samples were collected at designated timepoints. PK parameters of Paroxetine were calculated using non-compartmental methods. Statistical analysis of PK parameters was done using mixed effect model for evaluation of BE. Point estimate and associated adjusted 90% CI of difference between both the treatments were provided for AUC(0-infinity).
Time Frame	Pre-dose, 0.5 hour, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 7 hours, 8 hours, 10 hours, 12 hours, 16 hours, 24 hours, 36 hours, 48 hours, 72 hours and 96 hours post-dose in each treatment period

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Paroxetine 40 mg, GSKT- Fasted	Paroxetine 40 mg, Mississauga- Fasted
Arm/Group Description	Eligible participants received a single dose of treatment A: GSKT, Paroxetine IR 40 mg (20 mg*2 tablets) administered orally on Day 1 in either treatment period 1 or 2 as per randomization under fasting condition.	Eligible participants received a single dose of treatment B: Mississauga, Paroxetine IR 40 mg (20 mg*2 tablets) administered orally on Day 1 in either treatment period 1 or 2 as per randomization under fasting condition.
Measure Participants	36	36
Geometric Mean (90% Confidence Interval) [Hour*nanogram per milliliter]	742.07	745.22

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Paroxetine 40 mg, GSKT- Fed, Paroxetine 40 mg, Mississauga- Fed
	Comments
	Type of Statistical Test	Equivalence
	Comments	The two formulations were considered to be bioequivalent if the 90% confidence interval of AUC(0-infinity) for difference between both treatments fall in the range of 0.80-1.25.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Ratio of Geometrical Mean
	Estimated Value	0.996
	Confidence Interval	(2-Sided) 90%; 0.947 to 1.047
	Parameter Dispersion	Type: Value:
	Estimation Comments

3. Primary Outcome

Title	Area Under the Concentration-time Curve From Administration Extrapolated to the Last Time of Quantifiable Concentration (AUC[0-t]) of Paroxetine Following Single Oral Dose in Healthy Chinese Participants Under Fed Condition
Description	Blood samples were collected at designated timepoints. PK parameters of Paroxetine were calculated using non-compartmental methods. Statistical analysis of PK parameters was done using mixed effect model for evaluation of BE. Point estimate and associated adjusted 90% CI of difference between both the treatments were provided for AUC(0-t).
Time Frame	Pre-dose, 0.5 hour, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 7 hours, 8 hours, 10 hours, 12 hours, 16 hours, 24 hours, 36 hours, 48 hours, 72 hours and 96 hours post-dose in each treatment period

Outcome Measure Data

Analysis Population Description

BE analysis Population

Arm/Group Title	Paroxetine 40 mg, GSKT- Fed	Paroxetine 40 mg, Mississauga- Fed
Arm/Group Description	Eligible participants received a single dose of treatment A: GSKT, Paroxetine IR 40 mg (20 mg*2 tablets) administered orally on Day 1 in either treatment period 1 or 2 as per randomization under fed condition.	Eligible participants received a single dose of treatment B: Mississauga, Paroxetine IR 40 mg (20 mg*2 tablets) administered orally on Day 1 in either treatment period 1 or 2 as per randomization under fed condition.
Measure Participants	41	41
Geometric Mean (90% Confidence Interval) [Hour*nanogram per milliliter]	866.85	814.75

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Paroxetine 40 mg, GSKT- Fed, Paroxetine 40 mg, Mississauga- Fed
	Comments
	Type of Statistical Test	Equivalence
	Comments	The two formulations were considered to be bioequivalent if the 90% confidence interval of AUC(0-t) for difference between both treatments fall in the range of 0.80-1.25.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Ratio of Geometrical Mean
	Estimated Value	1.064
	Confidence Interval	(2-Sided) 90%; 1.010 to 1.120
	Parameter Dispersion	Type: Value:
	Estimation Comments

4. Primary Outcome

Title	AUC(0-t) of Paroxetine Following Single Oral Dose in Healthy Chinese Participants Under Fasting Condition
Description	Blood samples were collected at designated timepoints. PK parameters of Paroxetine were calculated using non-compartmental methods. Statistical analysis of PK parameters was done using mixed effect model for evaluation of BE. Point estimate and associated adjusted 90% CI of difference between both the treatments were provided for AUC(0-t).
Time Frame	Pre-dose, 0.5 hour, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 7 hours, 8 hours, 10 hours, 12 hours, 16 hours, 24 hours, 36 hours, 48 hours, 72 hours and 96 hours post-dose in each treatment period

Outcome Measure Data

Analysis Population Description

BE analysis Population

Arm/Group Title	Paroxetine 40 mg, GSKT- Fasted	Paroxetine 40 mg, Mississauga- Fasted
Arm/Group Description	Eligible participants received a single dose of treatment A: GSKT, Paroxetine IR 40 mg (20 mg*2 tablets) administered orally on Day 1 in either treatment period 1 or 2 as per randomization under fasting condition.	Eligible participants received a single dose of treatment B: Mississauga, Paroxetine IR 40 mg (20 mg*2 tablets) administered orally on Day 1 in either treatment period 1 or 2 as per randomization under fasting condition.
Measure Participants	37	37
Geometric Mean (90% Confidence Interval) [Hour*nanogram per milliliter]	750.49	753.83

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Paroxetine 40 mg, GSKT- Fed, Paroxetine 40 mg, Mississauga- Fed
	Comments
	Type of Statistical Test	Equivalence
	Comments	The two formulations were considered to be bioequivalent if the 90% confidence interval of AUC(0-t) for difference between both treatments fall in the range of 0.80-1.25.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Ratio of Geometrical Mean
	Estimated Value	0.996
	Confidence Interval	(2-Sided) 90%; 0.949 to 1.044
	Parameter Dispersion	Type: Value:
	Estimation Comments

5. Primary Outcome

Title	Maximum Observed Concentration (Cmax) of Paroxetine Following Single Oral Dose in Healthy Chinese Participants Under Fed Condition
Description	Blood samples were collected at designated timepoints. PK parameters of Paroxetine were calculated using non-compartmental methods. Statistical analysis of PK parameters was done using mixed effect model for evaluation of BE. Point estimate and associated adjusted 90% CI of difference between both the treatments were provided for Cmax.
Time Frame	Pre-dose, 0.5 hour, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 7 hours, 8 hours, 10 hours, 12 hours, 16 hours, 24 hours, 36 hours, 48 hours, 72 hours and 96 hours post-dose in each treatment period

Outcome Measure Data

Analysis Population Description

BE analysis Population

Arm/Group Title	Paroxetine 40 mg, GSKT- Fed	Paroxetine 40 mg, Mississauga- Fed
Arm/Group Description	Eligible participants received a single dose of treatment A: GSKT, Paroxetine IR 40 mg (20 mg*2 tablets) administered orally on Day 1 in either treatment period 1 or 2 as per randomization under fed condition.	Eligible participants received a single dose of treatment B: Mississauga, Paroxetine IR 40 mg (20 mg*2 tablets) administered orally on Day 1 in either treatment period 1 or 2 as per randomization under fed condition.
Measure Participants	41	41
Geometric Mean (90% Confidence Interval) [Nanogram per milliliter]	39.95	39.02

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Paroxetine 40 mg, GSKT- Fed, Paroxetine 40 mg, Mississauga- Fed
	Comments
	Type of Statistical Test	Equivalence
	Comments	The two formulations were considered to be bioequivalent if the 90% confidence interval of Cmax for difference between both treatments fall in the range of 0.80-1.25.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Ratio of Geometrical Mean
	Estimated Value	1.024
	Confidence Interval	(2-Sided) 90%; 0.952 to 1.101
	Parameter Dispersion	Type: Value:
	Estimation Comments

6. Primary Outcome

Title	Cmax of Paroxetine Following Single Oral Dose in Healthy Chinese Participants Under Fasting Condition
Description	Blood samples were collected at designated timepoints. PK parameters of Paroxetine were calculated using non-compartmental methods. Statistical analysis of PK parameters was done using mixed effect model for evaluation of BE. Point estimate and associated adjusted 90% CI of difference between both the treatments were provided for Cmax.
Time Frame	Pre-dose, 0.5 hour, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 7 hours, 8 hours, 10 hours, 12 hours, 16 hours, 24 hours, 36 hours, 48 hours, 72 hours and 96 hours post-dose in each treatment period

Outcome Measure Data

Analysis Population Description

BE analysis Population.

Arm/Group Title	Paroxetine 40 mg, GSKT- Fasted	Paroxetine 40 mg, Mississauga- Fasted
Arm/Group Description	Eligible participants received a single dose of treatment A: GSKT, Paroxetine IR 40 mg (20 mg*2 tablets) administered orally on Day 1 in either treatment period 1 or 2 as per randomization under fasting condition.	Eligible participants received a single dose of treatment B: Mississauga, Paroxetine IR 40 mg (20 mg*2 tablets) administered orally on Day 1 in either treatment period 1 or 2 as per randomization under fasting condition.
Measure Participants	37	37
Geometric Mean (90% Confidence Interval) [Nanogram per milliliter]	36.86	36.15

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Paroxetine 40 mg, GSKT- Fed, Paroxetine 40 mg, Mississauga- Fed
	Comments
	Type of Statistical Test	Equivalence
	Comments	The two formulations were considered to be bioequivalent if the 90% confidence interval of Cmax for difference between both treatments fall in the range of 0.80-1.25.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Ratio of Geometrical Mean
	Estimated Value	1.020
	Confidence Interval	(2-Sided) 90%; 0.968 to 1.074
	Parameter Dispersion	Type: Value:
	Estimation Comments

7. Secondary Outcome

Title	Time to Reach Maximum Observed Concentration (Tmax) of Paroxetine Following Single Oral Dose in Healthy Chinese Participants Under Fed Condition
Description	Blood samples were collected at designated timepoints. PK parameters of Paroxetine were calculated using non-compartmental methods. Median and full range of Tmax have been presented.
Time Frame	Pre-dose, 0.5 hour, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 7 hours, 8 hours, 10 hours, 12 hours, 16 hours, 24 hours, 36 hours, 48 hours, 72 hours and 96 hours post-dose in each treatment period

Outcome Measure Data

Analysis Population Description

Pharmacokinetic Population. PK Population comprised of all randomized participants received at least one dose of study treatment and provided at least one evaluable PK concentration data. Only those participants with data available at the specified data points were analyzed.

Arm/Group Title	Paroxetine 40 mg, GSKT- Fed	Paroxetine 40 mg, Mississauga- Fed
Arm/Group Description	Eligible participants received a single dose of treatment A: GSKT, Paroxetine IR 40 mg (20 mg*2 tablets) administered orally on Day 1 in either treatment period 1 or 2 as per randomization under fed condition.	Eligible participants received a single dose of treatment B: Mississauga, Paroxetine IR 40 mg (20 mg*2 tablets) administered orally on Day 1 in either treatment period 1 or 2 as per randomization under fed condition.
Measure Participants	43	45
Median (Full Range) [Hours]	5.00	5.00

8. Secondary Outcome

Title	Tmax of Paroxetine Following Single Oral Dose in Healthy Chinese Participants Under Fasting Condition
Description	Blood samples were collected at designated timepoints. PK parameters of Paroxetine were calculated using non-compartmental methods. Median and full range of Tmax have been presented.
Time Frame	Pre-dose, 0.5 hour, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 7 hours, 8 hours, 10 hours, 12 hours, 16 hours, 24 hours, 36 hours, 48 hours, 72 hours and 96 hours post-dose in each treatment period

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Paroxetine 40 mg, GSKT- Fasted	Paroxetine 40 mg, Mississauga- Fasted
Arm/Group Description	Eligible participants received a single dose of treatment A: GSKT, Paroxetine IR 40 mg (20 mg*2 tablets) administered orally on Day 1 in either treatment period 1 or 2 as per randomization under fasting condition.	Eligible participants received a single dose of treatment B: Mississauga, Paroxetine IR 40 mg (20 mg*2 tablets) administered orally on Day 1 in either treatment period 1 or 2 as per randomization under fasting condition.
Measure Participants	38	37
Median (Full Range) [Hours]	5.00	5.00

9. Secondary Outcome

Title	Terminal Elimination Rate Constant (Lambda z) of Paroxetine Following Single Oral Dose in Healthy Chinese Participants Under Fed Condition
Description	Blood samples were collected at designated timepoints. PK parameters of Paroxetine were calculated using non-compartmental methods. Geometric mean and 95% CI of Lambda z have been presented.
Time Frame	Pre-dose, 0.5 hour, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 7 hours, 8 hours, 10 hours, 12 hours, 16 hours, 24 hours, 36 hours, 48 hours, 72 hours and 96 hours post-dose in each treatment period

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Paroxetine 40 mg, GSKT- Fed	Paroxetine 40 mg, Mississauga- Fed
Arm/Group Description	Eligible participants received a single dose of treatment A: GSKT, Paroxetine IR 40 mg (20 mg*2 tablets) administered orally on Day 1 in either treatment period 1 or 2 as per randomization under fed condition.	Eligible participants received a single dose of treatment B: Mississauga, Paroxetine IR 40 mg (20 mg*2 tablets) administered orally on Day 1 in either treatment period 1 or 2 as per randomization under fed condition.
Measure Participants	43	45
Geometric Mean (95% Confidence Interval) [Per hour]	0.0433	0.0462

10. Secondary Outcome

Title	Lambda z of Paroxetine Following Single Oral Dose in Healthy Chinese Participants Under Fasting Condition
Description	Blood samples were collected at designated timepoints. PK parameters of Paroxetine were calculated using non-compartmental methods. Geometric mean and 95% CI of Lambda z have been presented.
Time Frame	Pre-dose, 0.5 hour, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 7 hours, 8 hours, 10 hours, 12 hours, 16 hours, 24 hours, 36 hours, 48 hours, 72 hours and 96 hours post-dose in each treatment period

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Paroxetine 40 mg, GSKT- Fasted	Paroxetine 40 mg, Mississauga- Fasted
Arm/Group Description	Eligible participants received a single dose of treatment A: GSKT, Paroxetine IR 40 mg (20 mg*2 tablets) administered orally on Day 1 in either treatment period 1 or 2 as per randomization under fasting condition.	Eligible participants received a single dose of treatment B: Mississauga, Paroxetine IR 40 mg (20 mg*2 tablets) administered orally on Day 1 in either treatment period 1 or 2 as per randomization under fasting condition.
Measure Participants	38	37
Geometric Mean (95% Confidence Interval) [Per hour]	0.0483	0.0494

11. Secondary Outcome

Title	Terminal Elimination Half-life (t1/2) of Paroxetine Following Single Oral Dose in Healthy Chinese Participants Under Fed Condition
Description	Blood samples were collected at designated timepoints. PK parameters of Paroxetine were calculated using non-compartmental methods. Geometric mean and 95% CI have been presented.
Time Frame	Pre-dose, 0.5 hour, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 7 hours, 8 hours, 10 hours, 12 hours, 16 hours, 24 hours, 36 hours, 48 hours, 72 hours and 96 hours post-dose in each treatment period

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Paroxetine 40 mg, GSKT- Fed	Paroxetine 40 mg, Mississauga- Fed
Arm/Group Description	Eligible participants received a single dose of treatment A: GSKT, Paroxetine IR 40 mg (20 mg*2 tablets) administered orally on Day 1 in either treatment period 1 or 2 as per randomization under fed condition.	Eligible participants received a single dose of treatment B: Mississauga, Paroxetine IR 40 mg (20 mg*2 tablets) administered orally on Day 1 in either treatment period 1 or 2 as per randomization under fed condition.
Measure Participants	43	45
Geometric Mean (95% Confidence Interval) [Hours]	16.0002	14.9913

12. Secondary Outcome

Title	t1/2 of Paroxetine Following Single Oral Dose in Healthy Chinese Participants Under Fasting Condition
Description	Blood samples were collected at designated timepoints. PK parameters of Paroxetine were calculated using non-compartmental methods. Geometric mean and 95% CI have been presented.
Time Frame	Pre-dose, 0.5 hour, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 7 hours, 8 hours, 10 hours, 12 hours, 16 hours, 24 hours, 36 hours, 48 hours, 72 hours and 96 hours post-dose in each treatment period

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Paroxetine 40 mg, GSKT- Fasted	Paroxetine 40 mg, Mississauga- Fasted
Arm/Group Description	Eligible participants received a single dose of treatment A: GSKT, Paroxetine IR 40 mg (20 mg*2 tablets) administered orally on Day 1 in either treatment period 1 or 2 as per randomization under fasting condition.	Eligible participants received a single dose of treatment B: Mississauga, Paroxetine IR 40 mg (20 mg*2 tablets) administered orally on Day 1 in either treatment period 1 or 2 as per randomization under fasting condition.
Measure Participants	38	37
Geometric Mean (95% Confidence Interval) [Hours]	14.3515	14.0311

13. Secondary Outcome

Title	Number of Participants With Non-serious Adverse Events and Serious Adverse Events (SAEs) Under Fed Condition
Description	An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect and other situations according to medical or scientific judgement or events associated with liver injury and impaired liver function. Data has been presented treatment-wise.
Time Frame	Up to Day 26

Outcome Measure Data

Analysis Population Description

Safety Population. Safety Population comprised of all randomized participants who received at least one dose of study treatment. Only those participants with data available at the specified data points were analyzed.

Arm/Group Title	Paroxetine 40 mg, GSKT- Fed	Paroxetine 40 mg, Mississauga- Fed
Arm/Group Description	Eligible participants received a single dose of treatment A: GSKT, Paroxetine IR 40 mg (20 mg*2 tablets) administered orally on Day 1 in either treatment period 1 or 2 as per randomization under fed condition.	Eligible participants received a single dose of treatment B: Mississauga, Paroxetine IR 40 mg (20 mg*2 tablets) administered orally on Day 1 in either treatment period 1 or 2 as per randomization under fed condition.
Measure Participants	44	46
Any non-SAEs	14 60.9%	13 54.2%
Any SAEs	0 0%	0 0%

14. Secondary Outcome

Title	Number of Participants With Non-SAE and SAEs Under Fasting Condition
Description	An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect and other situations according to medical or scientific judgement or events associated with liver injury and impaired liver function. Data has been presented treatment-wise.
Time Frame	Up to Day 26

Outcome Measure Data

Analysis Population Description

Safety Population

Arm/Group Title	Paroxetine 40 mg, GSKT- Fasted	Paroxetine 40 mg, Mississauga- Fasted
Arm/Group Description	Eligible participants received a single dose of treatment A: GSKT, Paroxetine IR 40 mg (20 mg*2 tablets) administered orally on Day 1 in either treatment period 1 or 2 as per randomization under fasting condition.	Eligible participants received a single dose of treatment B: Mississauga, Paroxetine IR 40 mg (20 mg*2 tablets) administered orally on Day 1 in either treatment period 1 or 2 as per randomization under fasting condition.
Measure Participants	38	38
Any non-SAEs	12 52.2%	16 66.7%
Any SAEs	0 0%	0 0%

15. Secondary Outcome

Title	Number of Participants With Chemistry Laboratory Values Relative to Potential Clinical Importance (PCI) Criteria on Day 16 Under Fed Condition
Description	Blood samples were collected to analyze the clinical chemistry laboratory parameters; alanine aminotransferase (ALT), albumin, alkaline phosphatase (ALP), aspartate aminotransferase (AST),calcium,creatinine, glucose, potassium (Pot) and sodium. PCI ranges were ALT (high: >=2 times upper limit of normal [ULN] units per liter [U/L]),albumin (low: <30 grams per liter),ALP (low: <20 international units per liter [IU/L] and high: >200 IU/L), AST (high: >=2 times ULN U/L),calcium (low: <2 millimoles per liter [mmol/L] and high: >2.75 mmol/L),creatinine (high: >133 micromoles per liter), glucose (low: <3 mmol/L and high: >9 mmol/L), Pot (low: <3 mmol/L and high: >5.5 mmol/L) and sodium (low: <130 mmol/L and high: >150 mmol/L). Participants were counted in the category that their value changed to (low, normal or high). If values were unchanged (example: High to High), or whose value became normal, were recorded in the 'To Normal or No Change' category. Data has been presented treatment-wise.
Time Frame	Day 16

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Paroxetine 40 mg, GSKT- Fed	Paroxetine 40 mg, Mississauga- Fed
Arm/Group Description	Eligible participants received a single dose of treatment A: GSKT, Paroxetine IR 40 mg (20 mg*2 tablets) administered orally on Day 1 in either treatment period 1 or 2 as per randomization under fed condition.	Eligible participants received a single dose of treatment B: Mississauga, Paroxetine IR 40 mg (20 mg*2 tablets) administered orally on Day 1 in either treatment period 1 or 2 as per randomization under fed condition.
Measure Participants	22	22
ALT, To low	0 0%	0 0%
ALT, To normal or no change	22 95.7%	22 91.7%
ALT, To high	0 0%	0 0%
Albumin, To low	0 0%	0 0%
Albumin, To normal or no change	22 95.7%	22 91.7%
Albumin, To high	0 0%	0 0%
ALP, To low	0 0%	0 0%
ALP, To normal or no change	22 95.7%	22 91.7%
ALP, To high	0 0%	0 0%
AST, To low	0 0%	0 0%
AST, To normal or no change	22 95.7%	22 91.7%
AST, To high	0 0%	0 0%
Calcium, To low	0 0%	0 0%
Calcium, To normal or no change	22 95.7%	22 91.7%
Calcium, To high	0 0%	0 0%
Creatinine, To low	0 0%	0 0%
Creatinine, To normal or no change	22 95.7%	22 91.7%
Creatinine, To high	0 0%	0 0%
Glucose, To low	0 0%	0 0%
Glucose, To normal or no change	22 95.7%	22 91.7%
Glucose, To high	0 0%	0 0%
Pot, To low	0 0%	0 0%
Pot, To normal or no change	22 95.7%	22 91.7%
Pot, To high	0 0%	0 0%
Sodium, To low	0 0%	0 0%
Sodium, To normal or no change	22 95.7%	22 91.7%
Sodium, To high	0 0%	0 0%

16. Secondary Outcome

Title	Number of Participants With Chemistry Laboratory Values Relative to PCI Criteria on Day 16 Under Fasting Condition
Description	Blood samples were collected to analyze the clinical chemistry laboratory parameters; ALT, albumin, ALP, AST, calcium, creatinine, glucose, Pot and sodium. PCI ranges were ALT (high: >=2 times ULN U/L), albumin (low: <30 grams per liter), ALP (low: <20 IU/L and high: >200 IU/L), AST (high: >=2 times ULN U/L), calcium (low: <2 mmol/L and high: >2.75 mmol/L), creatinine (high: >133 micromoles per liter), glucose (low: <3 mmol/L and high: >9 mmol/L), Pot (low: <3 mmol/L and high: >5.5 mmol/L) and sodium (low: <130 mmol/L and high: >150 mmol/L). Participants were counted in the category that their value changed to (low, normal or high). If values were unchanged (example: High to High), or whose value became normal, were recorded in the 'To Normal or No Change' category. Data has been presented treatment-wise.
Time Frame	Day 16

Outcome Measure Data

Analysis Population Description

Safety Population

Arm/Group Title	Paroxetine 40 mg, GSKT- Fasted	Paroxetine 40 mg, Mississauga- Fasted
Arm/Group Description	Eligible participants received a single dose of treatment A: GSKT, Paroxetine IR 40 mg (20 mg*2 tablets) administered orally on Day 1 in either treatment period 1 or 2 as per randomization under fasting condition.	Eligible participants received a single dose of treatment B: Mississauga, Paroxetine IR 40 mg (20 mg*2 tablets) administered orally on Day 1 in either treatment period 1 or 2 as per randomization under fasting condition.
Measure Participants	19	19
ALT, To low	0 0%	0 0%
ALT, To normal or no change	19 82.6%	19 79.2%
ALT, To high	0 0%	0 0%
Albumin, To low	0 0%	0 0%
Albumin, To normal or no change	19 82.6%	19 79.2%
Albumin, To high	0 0%	0 0%
ALP, To low	0 0%	0 0%
ALP, To normal or no change	19 82.6%	19 79.2%
ALP, To high	0 0%	0 0%
AST, To low	0 0%	0 0%
AST, To normal or no change	19 82.6%	19 79.2%
AST, To high	0 0%	0 0%
Calcium, To low	0 0%	0 0%
Calcium, To normal or no change	19 82.6%	19 79.2%
Calcium, To high	0 0%	0 0%
Creatinine, To low	0 0%	0 0%
Creatinine, To normal or no change	19 82.6%	19 79.2%
Creatinine, To high	0 0%	0 0%
Glucose, To low	0 0%	0 0%
Glucose, To normal or no change	19 82.6%	19 79.2%
Glucose, To high	0 0%	0 0%
Pot, To low	0 0%	0 0%
Pot, To normal or no change	19 82.6%	19 79.2%
Pot, To high	0 0%	0 0%
Sodium, To low	0 0%	0 0%
Sodium, To normal or no change	19 82.6%	19 79.2%
Sodium, To high	0 0%	0 0%

17. Secondary Outcome

Title	Number of Participants With Hematology Laboratory Values Relative to PCI Criteria on Day 16 Under Fed Condition
Description	Blood samples were collected to analyze; hematocrit(Hct),hemoglobin(Hb),erythrocytes and platelets. PCI ranges; Hct(Male[low: <0.03 proportion of red blood cells in blood and high: >0.54 proportion of red blood cells in blood] and Female[low: <0.04 proportion of red blood cells in blood and high: >0.54 proportion of red blood cells in blood]),Hb(Male [low: <110 grams per liter and high: >180 grams per liter) and Female[low: <100 grams per liter and high: >170 grams per liter]),erythrocytes(Male [low: <4.5x10^12 cells per liter and high: >5.5x10^12 cells per liter] and Female[low: <4 x10^12 cells per liter and high: >5 x10^12 cells per liter]) and platelets(low: <80x10^9 cells per liter and high: >400x10^9 cells per liter). Participants were counted in the category that their value changed to(low, normal or high). If values were unchanged(example: High to High), or whose value became normal, were recorded in the 'To Normal or No Change' category.Data has been presented treatment-wise.
Time Frame	Day 16

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Paroxetine 40 mg, GSKT- Fed	Paroxetine 40 mg, Mississauga- Fed
Arm/Group Description	Eligible participants received a single dose of treatment A: GSKT, Paroxetine IR 40 mg (20 mg*2 tablets) administered orally on Day 1 in either treatment period 1 or 2 as per randomization under fed condition.	Eligible participants received a single dose of treatment B: Mississauga, Paroxetine IR 40 mg (20 mg*2 tablets) administered orally on Day 1 in either treatment period 1 or 2 as per randomization under fed condition.
Measure Participants	22	22
Erythrocytes, To low	2 8.7%	2 8.3%
Erythrocytes, To normal or no change	20 87%	19 79.2%
Erythrocytes, To high	0 0%	1 4.2%
Hct, To low	0 0%	0 0%
Hct, To normal or no change	22 95.7%	22 91.7%
Hct, To high	0 0%	0 0%
Hb, To low	0 0%	0 0%
Hb, To normal or no change	22 95.7%	22 91.7%
Hb, To high	0 0%	0 0%
Platelets, To low	0 0%	0 0%
Platelets, To normal or no change	22 95.7%	22 91.7%
Platelets, To high	0 0%	0 0%

18. Secondary Outcome

Title	Number of Participants With Hematology Laboratory Values Relative to PCI Criteria on Day 16 Under Fasting Condition
Description	Blood samples were collected to analyze; Hct, Hb, erythrocytes and platelets. PCI ranges were Hct (Male [low: <0.03 proportion of red blood cells in blood and high: >0.54 proportion of red blood cells in blood] and Female [low: <0.04 proportion of red blood cells in blood and high: >0.54 proportion of red blood cells in blood]), Hb (Male [low: <110 grams per liter and high: >180 grams per liter) and Female [low: <100 grams per liter and high: >170 grams per liter]), erythrocytes (Male [low: <4.5x10^12 cells per liter and high: >5.5x10^12 cells per liter] and Female [low: <4 x10^12 cells per liter and high: >5 x10^12 cells per liter]) and platelets (low: <80x10^9 cells per liter and high: >400x10^9 cells per liter). Participants were counted in the category that their value changed to (low, normal or high). If values were unchanged (example: High to High), or whose value became normal, were recorded in the 'To Normal or No Change' category. Data has been presented treatment-wise.
Time Frame	Day 16

Outcome Measure Data

Analysis Population Description

Safety Population

Arm/Group Title	Paroxetine 40 mg, GSKT- Fasted	Paroxetine 40 mg, Mississauga- Fasted
Arm/Group Description	Eligible participants received a single dose of treatment A: GSKT, Paroxetine IR 40 mg (20 mg*2 tablets) administered orally on Day 1 in either treatment period 1 or 2 as per randomization under fasting condition.	Eligible participants received a single dose of treatment B: Mississauga, Paroxetine IR 40 mg (20 mg*2 tablets) administered orally on Day 1 in either treatment period 1 or 2 as per randomization under fasting condition.
Measure Participants	19	19
Erythrocytes, To low	1 4.3%	0 0%
Erythrocytes, To normal or no change	18 78.3%	19 79.2%
Erythrocytes, To high	0 0%	0 0%
Hct, To low	0 0%	0 0%
Hct, To normal or no change	19 82.6%	19 79.2%
Hct, To high	0 0%	0 0%
Hb, To low	0 0%	0 0%
Hb, To normal or no change	19 82.6%	19 79.2%
Hb, To high	0 0%	0 0%
Platelets, To low	0 0%	0 0%
Platelets, To normal or no change	19 82.6%	19 79.2%
Platelets, To high	0 0%	0 0%

19. Secondary Outcome

Title	Number of Participants With Urinalysis Results by Dipstick Method Under Fed Condition
Description	Urine samples were collected to assess urine occult blood, urine glucose, urine ketones, urine protein and monitor urine potential of hydrogen (pH). The dipstick test gave results in a semi-quantitative manner, and results for urinalysis parameters (except urine pH) were recorded as negative and positive, indicating proportional concentrations in the urine sample. pH is a measure of hydrogen ion concentration and is used to determine the acidity or alkalinity of urine. Urine pH is calculated on a scale of 0 to 14, values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH of less than 7 is acidic and a pH of greater than 7 is basic. Normal urine has a slightly acidic pH (5.0-6.0). Dipstick test results for pH were presented as number of participants having pH value as 5, 6, 6.5, 7 or 8. Data has been presented treatment-wise.
Time Frame	Baseline (Day-7 to Day -1) and Day 16

Outcome Measure Data

Analysis Population Description

Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).

Arm/Group Title	Paroxetine 40 mg, GSKT- Fed	Paroxetine 40 mg, Mississauga- Fed
Arm/Group Description	Eligible participants received a single dose of treatment A: GSKT, Paroxetine IR 40 mg (20 mg*2 tablets) administered orally on Day 1 in either treatment period 1 or 2 as per randomization under fed condition.	Eligible participants received a single dose of treatment B: Mississauga, Paroxetine IR 40 mg (20 mg*2 tablets) administered orally on Day 1 in either treatment period 1 or 2 as per randomization under fed condition.
Measure Participants	22	25
Glucose, Baseline, Negative, n=22,25	22 95.7%	25 104.2%
Glucose, Baseline, Positive, n=22,25	0 0%	0 0%
Glucose, Day 16, Negative, n=22,22	22 95.7%	22 91.7%
Glucose, Day 16, Positive, n=22,22	0 0%	0 0%
Ketones, Baseline, Positive, n=22,25	2 8.7%	1 4.2%
Ketones, Baseline, Negative, n=22,25	20 87%	24 100%
Ketones, Day 16, Positive,n=22,22	1 4.3%	0 0%
Ketones, Day 16, Negative,n=22,22	21 91.3%	22 91.7%
Occult blood, Baseline, Positive,n=22,25	2 8.7%	3 12.5%
Occult blood, Baseline, Negative,n=22,25	20 87%	22 91.7%
Occult blood, Day 16, Positive,n=22,22	5 21.7%	3 12.5%
Occult blood, Day 16, Negative,n=22,22	17 73.9%	19 79.2%
Protein, Baseline, Negative,n=22,25	22 95.7%	25 104.2%
Protein, Baseline, Positive,n=22,25	0 0%	0 0%
Protein, Day 16, Positive,n=22,22	1 4.3%	0 0%
Protein, Day 16, Negative,n=22,22	21 91.3%	22 91.7%
pH=5, Baseline,n=22,25	1 4.3%	4 16.7%
pH=6, Baseline,n=22,25	7 30.4%	5 20.8%
pH=6.5, Baseline,n=22,25	3 13%	6 25%
pH=7, Baseline,n=22,25	9 39.1%	10 41.7%
pH=8, Baseline,n=22,25	2 8.7%	0 0%
pH=5, Day 16,n=22,22	2 8.7%	4 16.7%
pH=6, Day 16,n=22,22	12 52.2%	10 41.7%
pH=6.5, Day 16,n=22,22	4 17.4%	2 8.3%
pH=7, Day 16,n=22,22	4 17.4%	6 25%
pH=8, Day 16,n=22,22	0 0%	0 0%

20. Secondary Outcome

Title	Number of Participants With Urinalysis Results by Dipstick Method Under Fasting Condition
Description	Urine samples were collected to assess urine occult blood, urine glucose, urine ketones, urine protein and monitor urine pH. The dipstick test gave results in a semi-quantitative manner, and results for urinalysis parameters (except urine pH) were recorded as negative and positive, indicating proportional concentrations in the urine sample. pH is a measure of hydrogen ion concentration and is used to determine the acidity or alkalinity of urine. Urine pH is calculated on a scale of 0 to 14, values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH of less than 7 is acidic and a pH of greater than 7 is basic. Normal urine has a slightly acidic pH (5.0-6.0). Dipstick test results for pH were presented as number of participants having pH value as 5, 6, 6.5, 7 or 8. Data has been presented treatment-wise.
Time Frame	Baseline (Day-7 to Day -1) and Day 16

Outcome Measure Data

Analysis Population Description

Safety Population

Arm/Group Title	Paroxetine 40 mg, GSKT- Fasted	Paroxetine 40 mg, Mississauga- Fasted
Arm/Group Description	Eligible participants received a single dose of treatment A: GSKT, Paroxetine IR 40 mg (20 mg*2 tablets) administered orally on Day 1 in either treatment period 1 or 2 as per randomization under fasting condition.	Eligible participants received a single dose of treatment B: Mississauga, Paroxetine IR 40 mg (20 mg*2 tablets) administered orally on Day 1 in either treatment period 1 or 2 as per randomization under fasting condition.
Measure Participants	19	19
Glucose, Baseline, Negative,	19 82.6%	19 79.2%
Glucose, Baseline, Positive,	0 0%	0 0%
Glucose, Day 16, Negative,	19 82.6%	19 79.2%
Glucose, Day 16, Positive,	0 0%	0 0%
Ketones, Baseline, Negative	19 82.6%	19 79.2%
Ketones, Baseline, Positive	0 0%	0 0%
Ketones, Day 16,Positive	1 4.3%	1 4.2%
Ketones, Day 16, Negative	18 78.3%	18 75%
Occult blood, Baseline, Positive	0 0%	1 4.2%
Occult blood, Baseline, Negative	19 82.6%	18 75%
Occult blood, Day 16, Positive	3 13%	1 4.2%
Occult blood, Day 16, Negative	16 69.6%	18 75%
Protein, Baseline, Negative	19 82.6%	19 79.2%
Protein, Baseline, Positive	0 0%	0 0%
Protein, Day 16, Positive	0 0%	1 4.2%
Protein, Day 16, Negative	19 82.6%	18 75%
pH=5, Baseline	3 13%	2 8.3%
pH=6, Baseline	2 8.7%	3 12.5%
pH=6.5, Baseline	5 21.7%	4 16.7%
pH=7, Baseline	6 26.1%	9 37.5%
pH=8, Baseline	3 13%	1 4.2%
pH=5, Day 16	4 17.4%	6 25%
pH=6, Day 16	13 56.5%	11 45.8%
pH=6.5, Day 16	0 0%	0 0%
pH=7, Day 16	2 8.7%	2 8.3%
pH=8, Day 16	0 0%	0 0%

21. Secondary Outcome

Title	Number of Participants With Clinically Significant Abnormal Findings for Electrocardiogram (ECG) Parameters Under Fed Condition
Description	A single 12-lead ECGs was obtained using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT and QT corrected (QTc) intervals. Clinically significant abnormal ranges were: heart rate: lower:<50 beats per minute and upper: >110 beats per minute; QT: Upper: >400 milliseconds (msec); QTc: Upper: >450 msec; PR: lower: <110 msec and upper: >220 msec; QRS: lower: <60 msec and upper: >120 msec. The number of participants with abnormal findings for ECG parameters have been presented. Data has been presented treatment-wise.
Time Frame	Baseline (Day-7 to Day -1) and Day 16

Outcome Measure Data

Analysis Population Description

Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).

Arm/Group Title	Paroxetine 40 mg, GSKT- Fed	Paroxetine 40 mg, Mississauga- Fed
Arm/Group Description	Eligible participants received a single dose of treatment A: GSKT, Paroxetine IR 40 mg (20 mg*2 tablets) administered orally on Day 1 in either treatment period 1 or 2 as per randomization under fed condition.	Eligible participants received a single dose of treatment B: Mississauga, Paroxetine IR 40 mg (20 mg*2 tablets) administered orally on Day 1 in either treatment period 1 or 2 as per randomization under fed condition.
Measure Participants	22	25
Baseline, n=22, 25	0 0%	0 0%
Day 16, n=22, 22	1 4.3%	0 0%

22. Secondary Outcome

Title	Number of Participants With Clinically Significant Abnormal Findings for ECG Parameters Under Fasting Condition
Description	A single 12-lead ECGs was obtained using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT and QTc intervals. Clinically significant abnormal ranges were: heart rate: lower :<50 beats per minute and upper: >110 beats per minute; QT: Upper: >400 msec; QTc: Upper: >450 msec; PR: lower: <110 msec and upper: >220 msec; QRS: lower: <60 msec and upper: >120 msec. The number of participants with abnormal findings for ECG parameters have been presented. Data has been presented treatment-wise.
Time Frame	Baseline (Day-7 to Day -1) and Day 16

Outcome Measure Data

Analysis Population Description

Safety Population

Arm/Group Title	Paroxetine 40 mg, GSKT- Fasted	Paroxetine 40 mg, Mississauga- Fasted
Arm/Group Description	Eligible participants received a single dose of treatment A: GSKT, Paroxetine IR 40 mg (20 mg*2 tablets) administered orally on Day 1 in either treatment period 1 or 2 as per randomization under fasting condition.	Eligible participants received a single dose of treatment B: Mississauga, Paroxetine IR 40 mg (20 mg*2 tablets) administered orally on Day 1 in either treatment period 1 or 2 as per randomization under fasting condition.
Measure Participants	19	19
Baseline	0 0%	0 0%
Day 16	0 0%	0 0%

23. Secondary Outcome

Title	Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) at Indicated Time-points Under Fed Condition
Description	Vital signs including DBP and SBP were measured at the indicated time-points and summarized during the study to evaluate the safety of the participants. Data has been presented treatment-wise.
Time Frame	Day 1 (post-dose), Day 2 (post-dose), Day 3, Day 4, Day 5, Day 11, Day 12 (pre-dose), Day 12 (post-dose), Day 13 (post-dose), Day 14, Day 15, Day 16

Outcome Measure Data

Analysis Population Description

Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).

Arm/Group Title	Paroxetine 40 mg, GSKT- Fed	Paroxetine 40 mg, Mississauga- Fed
Arm/Group Description	Eligible participants received a single dose of treatment A: GSKT, Paroxetine IR 40 mg (20 mg*2 tablets) administered orally on Day 1 in either treatment period 1 or 2 as per randomization under fed condition.	Eligible participants received a single dose of treatment B: Mississauga, Paroxetine IR 40 mg (20 mg*2 tablets) administered orally on Day 1 in either treatment period 1 or 2 as per randomization under fed condition.
Measure Participants	23	24
DBP, Day 1 (post-dose), n=23,24	70.4 (9.27)	67.8 (6.84)
DBP, Day 2 (post-dose), n=23,24	69.0 (7.93)	66.8 (7.38)
DBP, Day 3, n=23,24	67.7 (7.11)	64.5 (5.27)
DBP, Day 4, n=23,24	67.5 (6.68)	66.1 (6.86)
DBP, Day 5, n=23,24	69.7 (6.98)	68.9 (7.31)
DBP, Day 11, n=21,22	69.9 (7.62)	70.5 (8.98)
DBP, Day 12 (pre-dose), n=21,22	71.2 (6.59)	72.7 (7.79)
DBP, Day 12 (post-dose), n=20,22	69.9 (7.71)	72.2 (7.67)
DBP, Day 13 (post-dose), n=20,22	70.3 (6.50)	72.9 (7.75)
DBP, Day 14, n=20,22	70.3 (8.15)	71.7 (7.09)
DBP, Day 15, n=20,22	68.8 (6.14)	70.4 (7.10)
DBP, Day 16, n=20,22	72.8 (8.42)	73.9 (6.65)
SBP, Day 1 (post-dose), n=23,24	112.4 (10.13)	111.8 (11.15)
SBP, Day 2 (post-dose), n=23,24	113.8 (9.07)	111.0 (10.19)
SBP, Day 3, n=23,24	112.9 (9.46)	109.4 (10.52)
SBP, Day 4, n=23,24	111.1 (10.83)	110.9 (10.97)
SBP, Day 5, n=23,24	109.2 (10.31)	109.8 (10.08)
SBP, Day 11, n=21,22	109.0 (10.89)	110.6 (9.18)
SBP, Day 12 (pre-dose), n=21,22	107.2 (9.54)	108.5 (8.34)
SBP, Day 12 (post-dose), n=20,22	112.4 (9.66)	112.4 (11.42)
SBP, Day 13 (post-dose), n=20,22	111.4 (10.18)	112.0 (8.80)
SBP, Day 14, n=20,22	107.0 (9.49)	105.5 (8.44)
SBP, Day 15, n=20,22	107.3 (7.73)	106.0 (9.62)
SBP, Day 16, n=20,22	107.1 (8.94)	105.9 (6.29)

24. Secondary Outcome

Title	DBP and SBP at Indicated Time-points Under Fasting Condition
Description	Vital signs including DBP and SBP were measured at the indicated time-points and summarized during the study to evaluate the safety of the participants. Data has been presented treatment-wise.
Time Frame	Day 1 (post-dose), Day 2 (post-dose), Day 3, Day 4, Day 5, Day 11, Day 12 (pre-dose), Day 12 (post-dose), Day 13 (post-dose), Day 14, Day 15, Day 16

Outcome Measure Data

Analysis Population Description

Safety Population

Arm/Group Title	Paroxetine 40 mg, GSKT- Fasted	Paroxetine 40 mg, Mississauga- Fasted
Arm/Group Description	Eligible participants received a single dose of treatment A: GSKT, Paroxetine IR 40 mg (20 mg*2 tablets) administered orally on Day 1 in either treatment period 1 or 2 as per randomization under fasting condition.	Eligible participants received a single dose of treatment B: Mississauga, Paroxetine IR 40 mg (20 mg*2 tablets) administered orally on Day 1 in either treatment period 1 or 2 as per randomization under fasting condition.
Measure Participants	19	19
DBP, Day 1 (post-dose)	71.8 (6.37)	70.9 (6.56)
DBP, Day 2 (post-dose)	68.3 (7.59)	68.7 (7.61)
DBP, Day 3	66.2 (6.99)	67.8 (9.22)
DBP, Day 4	68.3 (8.29)	68.8 (5.91)
DBP, Day 5	68.1 (6.16)	73.3 (7.31)
DBP, Day 11	71.9 (6.62)	71.4 (7.36)
DBP, Day 12 (pre-dose)	72.6 (8.00)	71.2 (9.11)
DBP, Day 12 (post-dose)	73.5 (6.29)	70.3 (7.59)
DBP, Day 13 (post-dose)	72.6 (6.72)	69.6 (7.22)
DBP, Day 14	72.2 (6.96)	70.2 (4.76)
DBP, Day 15	70.6 (7.65)	68.7 (8.39)
DBP, Day 16	71.9 (7.32)	71.1 (8.28)
SBP, Day 1 (post-dose)	107.4 (10.56)	109.2 (10.82)
SBP, Day 2 (post-dose)	108.1 (11.85)	110.1 (10.13)
SBP, Day 3	106.3 (10.19)	108.2 (12.21)
SBP, Day 4	105.1 (10.31)	107.4 (8.78)
SBP, Day 5	104.4 (9.17)	111.3 (12.03)
SBP, Day 11	113.2 (13.72)	111.4 (12.88)
SBP, Day 12 (pre-dose)	108.3 (10.40)	107.4 (9.63)
SBP, Day 12 (post-dose)	111.6 (9.63)	107.5 (8.84)
SBP, Day 13 (post-dose)	111.7 (10.50)	109.9 (11.86)
SBP, Day 14	110.5 (12.18)	104.5 (9.48)
SBP, Day 15	108.5 (10.56)	107.4 (9.63)
SBP, Day 16	110.7 (12.70)	104.2 (9.65)

25. Secondary Outcome

Title	Pulse Rate (PR) at Indicated Time-points Under Fed Condition
Description	Vital sign including PR was measured at the indicated time-points and summarized during the study to evaluate the safety of the participants. Data has been presented treatment-wise.
Time Frame	Day 1 (post-dose), Day 2 (post-dose), Day 3, Day 4, Day 5, Day 11, Day 12 (pre-dose), Day 12 (post-dose), Day 13 (post-dose), Day 14, Day 15, Day 16

Outcome Measure Data

Analysis Population Description

Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).

Arm/Group Title	Paroxetine 40 mg, GSKT- Fed	Paroxetine 40 mg, Mississauga- Fed
Arm/Group Description	Eligible participants received a single dose of treatment A: GSKT, Paroxetine IR 40 mg (20 mg*2 tablets) administered orally on Day 1 in either treatment period 1 or 2 as per randomization under fed condition.	Eligible participants received a single dose of treatment B: Mississauga, Paroxetine IR 40 mg (20 mg*2 tablets) administered orally on Day 1 in either treatment period 1 or 2 as per randomization under fed condition.
Measure Participants	23	24
Day 1 (post-dose), n=23,24	72.3 (10.57)	72.0 (8.83)
Day 2 (post-dose), n=23,24	72.8 (8.22)	74.1 (9.98)
Day 3, n=23,24	74.0 (9.11)	75.8 (10.07)
Day 4, n=23,24	75.5 (7.13)	75.7 (11.02)
Day 5, n=23,24	68.7 (7.03)	68.3 (8.87)
Day 11, n=21,22	75.0 (11.05)	77.7 (8.38)
Day 12 (pre-dose), n=21,22	65.8 (9.00)	64.7 (7.57)
Day 12 (post-dose), n=20,22	72.8 (10.85)	76.2 (10.15)
Day 13 (post-dose), n=20,22	73.7 (11.86)	73.8 (8.07)
Day 14, n=20,22	75.6 (10.72)	77.6 (9.88)
Day 15, n=20,22	77.5 (11.33)	75.5 (8.38)
Day 16, n=20,22	69.4 (8.54)	72.6 (9.51)

26. Secondary Outcome

Title	Pulse Rate (PR) at Indicated Time-points Under Fasting Condition
Description	Vital sign including PR was measured at the indicated time-points and summarized during the study to evaluate the safety of the participants. Data has been presented treatment-wise.
Time Frame	Day 1 (post-dose), Day 2 (post-dose), Day 3, Day 4, Day 5, Day 11, Day 12 (pre-dose), Day 12 (post-dose), Day 13 (post-dose), Day 14, Day 15, Day 16

Outcome Measure Data

Analysis Population Description

Safety Population

Arm/Group Title	Paroxetine 40 mg, GSKT- Fasted	Paroxetine 40 mg, Mississauga- Fasted
Arm/Group Description	Eligible participants received a single dose of treatment A: GSKT, Paroxetine IR 40 mg (20 mg*2 tablets) administered orally on Day 1 in either treatment period 1 or 2 as per randomization under fasting condition.	Eligible participants received a single dose of treatment B: Mississauga, Paroxetine IR 40 mg (20 mg*2 tablets) administered orally on Day 1 in either treatment period 1 or 2 as per randomization under fasting condition.
Measure Participants	19	19
Day 1 (post-dose)	65.4 (8.80)	67.5 (7.19)
Day 2 (post-dose)	74.8 (7.40)	75.3 (8.31)
Day 3	74.9 (8.45)	77.2 (10.69)
Day 4	74.2 (8.74)	72.8 (9.86)
Day 5	67.3 (6.82)	71.2 (9.60)
Day 11	81.8 (9.72)	84.1 (9.20)
Day 12 (pre-dose)	66.5 (8.73)	66.8 (10.48)
Day 12 (post-dose)	67.5 (8.96)	65.2 (7.19)
Day 13 (post-dose)	78.1 (11.03)	75.4 (7.54)
Day 14	78.9 (11.12)	76.8 (8.25)
Day 15	78.2 (8.38)	75.9 (9.58)
Day 16	75.7 (10.39)	71.3 (7.92)

27. Secondary Outcome

Title	Respiratory Rate (RR) at Indicated Time-point Under Fed Condition
Description	Vital sign including RR was measured at the indicated time-point and summarized during the study to evaluate the safety of the participants. Data has been presented treatment-wise.
Time Frame	Day 11

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Paroxetine 40 mg, GSKT- Fed	Paroxetine 40 mg, Mississauga- Fed
Arm/Group Description	Eligible participants received a single dose of treatment A: GSKT, Paroxetine IR 40 mg (20 mg*2 tablets) administered orally on Day 1 in either treatment period 1 or 2 as per randomization under fed condition.	Eligible participants received a single dose of treatment B: Mississauga, Paroxetine IR 40 mg (20 mg*2 tablets) administered orally on Day 1 in either treatment period 1 or 2 as per randomization under fed condition.
Measure Participants	21	22
Mean (Standard Deviation) [Breaths per minute]	17.8 (1.78)	18.6 (1.79)

28. Secondary Outcome

Title	RR at Indicated Time-point Under Fasting Condition
Description	Vital sign including RR was measured at the indicated time-point and summarized during the study to evaluate the safety of the participants. Data has been presented treatment-wise.
Time Frame	Day 11

Outcome Measure Data

Analysis Population Description

Safety Population

Arm/Group Title	Paroxetine 40 mg, GSKT- Fasted	Paroxetine 40 mg, Mississauga- Fasted
Arm/Group Description	Eligible participants received a single dose of treatment A: GSKT, Paroxetine IR 40 mg (20 mg*2 tablets) administered orally on Day 1 in either treatment period 1 or 2 as per randomization under fasting condition.	Eligible participants received a single dose of treatment B: Mississauga, Paroxetine IR 40 mg (20 mg*2 tablets) administered orally on Day 1 in either treatment period 1 or 2 as per randomization under fasting condition.
Measure Participants	19	19
Mean (Standard Deviation) [Breaths per minute]	19.2 (1.38)	19.4 (1.16)

29. Secondary Outcome

Title	Temperature at Indicated Time-point Under Fed Condition
Description	Vital sign including temperature was measured at the indicated time-point and summarized during the study to evaluate the safety of the participants. Data has been presented treatment-wise.
Time Frame	Day 11

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Paroxetine 40 mg, GSKT- Fed	Paroxetine 40 mg, Mississauga- Fed
Arm/Group Description	Eligible participants received a single dose of treatment A: GSKT, Paroxetine IR 40 mg (20 mg*2 tablets) administered orally on Day 1 in either treatment period 1 or 2 as per randomization under fed condition.	Eligible participants received a single dose of treatment B: Mississauga, Paroxetine IR 40 mg (20 mg*2 tablets) administered orally on Day 1 in either treatment period 1 or 2 as per randomization under fed condition.
Measure Participants	21	22
Mean (Standard Deviation) [Celsius]	36.70 (0.307)	36.59 (0.333)

30. Secondary Outcome

Title	Temperature at Indicated Time-point Under Fasting Condition
Description	Vital sign including temperature was measured at the indicated time-point and summarized during the study to evaluate the safety of the participants. Data has been presented treatment-wise.
Time Frame	Day 11

Outcome Measure Data

Analysis Population Description

Safety Population

Arm/Group Title	Paroxetine 40 mg, GSKT- Fasted	Paroxetine 40 mg, Mississauga- Fasted
Arm/Group Description	Eligible participants received a single dose of treatment A: GSKT, Paroxetine IR 40 mg (20 mg*2 tablets) administered orally on Day 1 in either treatment period 1 or 2 as per randomization under fasting condition.	Eligible participants received a single dose of treatment B: Mississauga, Paroxetine IR 40 mg (20 mg*2 tablets) administered orally on Day 1 in either treatment period 1 or 2 as per randomization under fasting condition.
Measure Participants	19	19
Mean (Standard Deviation) [Celsius]	36.84 (0.187)	36.74 (0.256)

Adverse Events

Time Frame	Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Day 26.
Adverse Event Reporting Description	SAEs and Non-SAEs were reported as per the treatment for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
Arm/Group Title	Paroxetine 40 mg, GSKT- Fed		Paroxetine 40 mg, Mississauga- Fed		Paroxetine 40 mg, GSKT- Fasted		Paroxetine 40 mg, Mississauga- Fasted
Arm/Group Description	Eligible participants received a single dose of treatment A: GSKT, Paroxetine IR 40 mg (20 mg*2 tablets) administered orally on Day 1 in either treatment period 1 or 2 as per randomization under fed condition.		Eligible participants received a single dose of treatment B: Mississauga, Paroxetine IR 40 mg (20 mg*2 tablets) administered orally on Day 1 in either treatment period 1 or 2 as per randomization under fed condition.		Eligible participants received a single dose of treatment A: GSKT, Paroxetine IR 40 mg (20 mg*2 tablets) administered orally on Day 1 in either treatment period 1 or 2 as per randomization under fasting condition.		Eligible participants received a single dose of treatment B: Mississauga, Paroxetine IR 40 mg (20 mg*2 tablets) administered orally on Day 1 in either treatment period 1 or 2 as per randomization under fasting condition.
All Cause Mortality
	Paroxetine 40 mg, GSKT- Fed		Paroxetine 40 mg, Mississauga- Fed		Paroxetine 40 mg, GSKT- Fasted		Paroxetine 40 mg, Mississauga- Fasted
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/44 (0%)		0/46 (0%)		0/38 (0%)		0/38 (0%)
Serious Adverse Events
	Paroxetine 40 mg, GSKT- Fed		Paroxetine 40 mg, Mississauga- Fed		Paroxetine 40 mg, GSKT- Fasted		Paroxetine 40 mg, Mississauga- Fasted
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/44 (0%)		0/46 (0%)		0/38 (0%)		0/38 (0%)
Other (Not Including Serious) Adverse Events
	Paroxetine 40 mg, GSKT- Fed		Paroxetine 40 mg, Mississauga- Fed		Paroxetine 40 mg, GSKT- Fasted		Paroxetine 40 mg, Mississauga- Fasted
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	14/44 (31.8%)		13/46 (28.3%)		12/38 (31.6%)		16/38 (42.1%)
Blood and lymphatic system disorders
Anaemia	1/44 (2.3%)		1/46 (2.2%)		0/38 (0%)		1/38 (2.6%)
Cardiac disorders
Sinus bradycardia	1/44 (2.3%)		0/46 (0%)		0/38 (0%)		0/38 (0%)
Eye disorders
Vision blurred	1/44 (2.3%)		0/46 (0%)		0/38 (0%)		1/38 (2.6%)
Gastrointestinal disorders
Diarrhoea	3/44 (6.8%)		2/46 (4.3%)		0/38 (0%)		2/38 (5.3%)
Nausea	1/44 (2.3%)		1/46 (2.2%)		5/38 (13.2%)		6/38 (15.8%)
Vomiting	1/44 (2.3%)		0/46 (0%)		0/38 (0%)		2/38 (5.3%)
Toothache	0/44 (0%)		2/46 (4.3%)		0/38 (0%)		0/38 (0%)
Mouth swelling	0/44 (0%)		1/46 (2.2%)		0/38 (0%)		0/38 (0%)
Oral pain	0/44 (0%)		1/46 (2.2%)		0/38 (0%)		0/38 (0%)
Abdominal pain	0/44 (0%)		0/46 (0%)		0/38 (0%)		2/38 (5.3%)
Investigations
Bacterial test	1/44 (2.3%)		1/46 (2.2%)		2/38 (5.3%)		1/38 (2.6%)
White blood cells urine positive	1/44 (2.3%)		1/46 (2.2%)		3/38 (7.9%)		3/38 (7.9%)
Alanine aminotransferase increased	1/44 (2.3%)		0/46 (0%)		0/38 (0%)		0/38 (0%)
Blood uric acid increased	1/44 (2.3%)		0/46 (0%)		0/38 (0%)		0/38 (0%)
Blood urine present	1/44 (2.3%)		0/46 (0%)		0/38 (0%)		0/38 (0%)
Occult blood positive	1/44 (2.3%)		0/46 (0%)		0/38 (0%)		0/38 (0%)
White blood cell count decreased	0/44 (0%)		3/46 (6.5%)		1/38 (2.6%)		0/38 (0%)
Bilirubin conjugated increased	0/44 (0%)		1/46 (2.2%)		1/38 (2.6%)		0/38 (0%)
Blood bilirubin increased	0/44 (0%)		1/46 (2.2%)		1/38 (2.6%)		0/38 (0%)
Blood glucose decreased	0/44 (0%)		1/46 (2.2%)		0/38 (0%)		0/38 (0%)
Gamma-glutamyltransferase increased	0/44 (0%)		1/46 (2.2%)		0/38 (0%)		0/38 (0%)
Blood cholesterol increased	0/44 (0%)		0/46 (0%)		1/38 (2.6%)		0/38 (0%)
Mean cell haemoglobin decreased	0/44 (0%)		0/46 (0%)		1/38 (2.6%)		0/38 (0%)
Mean cell volume decreased	0/44 (0%)		0/46 (0%)		1/38 (2.6%)		0/38 (0%)
White blood cell count increased	0/44 (0%)		0/46 (0%)		1/38 (2.6%)		0/38 (0%)
Bacterial test positive	0/44 (0%)		0/46 (0%)		0/38 (0%)		2/38 (5.3%)
Protein urine present	0/44 (0%)		0/46 (0%)		0/38 (0%)		1/38 (2.6%)
Urine ketone body present	0/44 (0%)		0/46 (0%)		0/38 (0%)		1/38 (2.6%)
Metabolism and nutrition disorders
Hypokalaemia	1/44 (2.3%)		1/46 (2.2%)		0/38 (0%)		0/38 (0%)
Nervous system disorders
Headache	2/44 (4.5%)		0/46 (0%)		0/38 (0%)		5/38 (13.2%)
Dizziness	1/44 (2.3%)		0/46 (0%)		6/38 (15.8%)		4/38 (10.5%)
Respiratory, thoracic and mediastinal disorders
Cough	1/44 (2.3%)		0/46 (0%)		0/38 (0%)		0/38 (0%)
Rhinorrhoea	1/44 (2.3%)		0/46 (0%)		0/38 (0%)		1/38 (2.6%)
Oropharyngeal pain	0/44 (0%)		0/46 (0%)		1/38 (2.6%)		0/38 (0%)
Skin and subcutaneous tissue disorders
Rash	1/44 (2.3%)		2/46 (4.3%)		0/38 (0%)		0/38 (0%)
Cold sweat	1/44 (2.3%)		0/46 (0%)		0/38 (0%)		0/38 (0%)
Rash generalised	0/44 (0%)		1/46 (2.2%)		0/38 (0%)		0/38 (0%)
Vascular disorders
Hypertension	0/44 (0%)		0/46 (0%)		0/38 (0%)		1/38 (2.6%)

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.