Bioequivalence of Two Formulations of Esomeprazole

• Sponsor: Yung Shin Pharm. Ind. Co., Ltd. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02543606
• Collaborator: Taichung Veterans General Hospital (Other)
• Enrollment: 14
• Location: 1
• Arms: 2
• Duration (Months): 2
• Patients Per Site Per Month: 7

Study Details

Study Description

Brief Summary

Bioequivalence of Two Formulations of Esomeprazole 40mg

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: Esomelone; Drug: Nexium	Phase 4

Detailed Description

A randomized, two-way crossover, single-dose pharmacokinetic study to evaluate the bioequivalence of a test formulation of Esomelone powder for solution for injection/infusion 40mg (Esomeprazole 40mg), compared to an equivalent dose of a reference drug product (Nexium powder for injection and infusion 40mg) in healthy adult subjects.

Study Design

• Study Type: Interventional
• Actual Enrollment: 14 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Randomized, Two-way Crossover, Single-dose Pharmacokinetic Study to Evaluate the Bioequivalence of Esomelone for Injection/Infusion (Esomeprazole 40mg), Compared to Reference Drug (Nexium 40mg) in Healthy Adult Subjects
• Study Start Date: Apr 1, 2015
• Actual Primary Completion Date: Jun 1, 2015
• Actual Study Completion Date: Jun 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Esomelone powder for injection/ infusion Esomeprazole 40mg	Drug: Esomelone; powder for injection/ infusion Esomeprazole 40mg; Drug: Nexium; powder for injection/ infusion Esomeprazole 40mg
Active Comparator: Nexium powder for injection/ infusion Esomeprazole 40mg	Drug: Esomelone; powder for injection/ infusion Esomeprazole 40mg; Drug: Nexium; powder for injection/ infusion Esomeprazole 40mg

Outcome Measures

Primary Outcome Measures

1. The pharmacokinetic parameters of ln transformed data ln(AUC) of the product. [pre-dose to 12 hours post dose]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 40 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

1. Healthy adult, aged between 20 to 40 years old.

2. Physically and mentally healthy subjects as confirmed by an interview, medical history, clinical examination, laboratory tests, chest x-ray and electrocardiogram.

• no particular clinical significance in clinical examination and laboratory tests within two months (60 days) prior to Period I dosing.

• normal or considered not clinically significant by the investigator chest X-ray and ECG results within six months (180 days ) prior to Period I dosing.

1. The normal range of the body mass index should be between 18.5 and 25; body mass index equals [weight (kg)]/[height (m)]2.

2. Normal laboratory determinations result (within normal range or considered not clinically significant by the investigator) including: SGOT (AST), SGPT (ALT), albumin, glucose, creatinine, uric acid, cholesterol, TG, r-GT, alkaline phosphatase, total bilirubin, BUN, HBsAg, Anti-HCV and Anti-HIV test.

3. Normal hematology results (within normal range or considered not clinically significant by the investigator) including: hemoglobin, hematocrit, WBC count with differential, RBC count and platelet count.

4. Normal urinalysis results (within normal range or considered not clinically significant by the investigator) including: glucose, protein, RBC, WBC, epith, casts and bacteria.

5. Female subject who is

• using adequate contraception since last menstruation and no plan for conception during the study,

• non-lactating.

• has negative pregnancy test (urine) within 14 days prior to the study.

1. Informed consent form signed.

Exclusion Criteria:

1. A history of drug or alcohol abuse during the past 24 weeks.

2. Sensitivity to analogous drug.

3. A clinically significant illness (such as significant unintentional weight loss, recurrent vomiting, dysphagia, haematemesis, melaena or gastric ulcer) within the past 4 weeks.

4. Evidence of any clinical significant renal, cardiovascular, hepatic, hematopoietic, neurological, pulmonary or gastrointestinal pathology within the past 4 weeks.

5. Planned vaccination during the time course of the study.

6. Participation of ant clinical investigation during the last 60 days.

7. Regular use of any medication during the last 4 weeks.

8. Single use of any medication during the last 2 weeks.

9. Blood donation of more than 250 mL within the past 12 weeks.

10. Individuals are judged by the investigation or co-investigator to be undesirable as subjects.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Taichung Veterans General Hospital	Taichung		Taiwan	40705

Sponsors and Collaborators

• Yung Shin Pharm. Ind. Co., Ltd.
• Taichung Veterans General Hospital

Investigators

• Principal Investigator: Hong-Zen Yeh, M.D., Taichung Veterans General Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Yung Shin Pharm. Ind. Co., Ltd.
• ClinicalTrials.gov Identifier: NCT02543606
• Other Study ID Numbers: YSP-RFH3002-01
• First Posted: Sep 7, 2015
• Last Update Posted: Sep 7, 2015
• Last Verified: Jul 1, 2015

• Additional relevant MeSH terms: Esomeprazole

Study Results

No Results Posted as of Sep 7, 2015