A Pharmacokinetic Study to Evaluate the Bioequivalence of a Test Formulation Compared to an Equivalent Dose of a Reference Drug Product

• Status: Unknown status
• Trial end date: 2015-06-01
• Target enrollment: 0
• Participant gender: All

Summary

To assess the bioequivalence of esomeprazole of the TEST product vs. the REFERENCE product in healthy volunteers who reside in Taiwan.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: isRed Pharma & Biotech Research Corporation
• Collaborator: Yung Shin Pharmaceutical Ind. Co., Ltd.
• Treatments: Esomeprazole

Criteria

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.

3. The normal range of the body mass index should between 18.5 and 25.

4. Normal laboratory determinations results including: SGOT (AST), SGPT (ALT), albumin, glucose, creatinine, uric acid, cholesterol, TG, γ-GT, alkaline phosphatase, total bilirubin, BUN, HBsAg, Anti-HCV and Anti-HIV test.

5. Normal hematology results including: hemoglobin, hematocrit, WBC count with differential, RBC count and platelet count.

6. Normal urinalysis results including: glucose, protein, RBC, WBC, epith, casts and bacteria.

7. 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.

8. 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, hematopoetic, neurological, pulmonary or gastrointestinal pathology within the past 4 weeks.

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

6. Participation of any 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 investigator or co-investigator to be undesirable as subjects.