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

Healthy Adult Subjects Clinical Trial

Official title:
A Randomized, Two-Way Crossover, Single-Dose Pharmacokinetic Study to Evaluate the Bioequivalence of a Test Formulation Compared to an Equivalent Dose of a Reference Drug Product (Nexium Powder for Injection and Infusion 40 mg) in Healthy Adult Subjects

Clinical Trial Summary

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

Clinical Trial Description

This study is designed to assess the bioequivalence of esomeprazole of the TEST product vs. the REFERENCE product in healthy volunteers who reside in Taiwan. Bioequivalence will be assumed if the 90% confidence interval of the AUC0-t, AUC0-inf and Cmax ratio are within the 80-125% interval for log-transformed values. ;

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject)

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02444507
Study type Interventional
Source isRed Pharma & Biotech Research Corporation
Contact Chen Chi Yuan
Phone 886-4-26623020
Email jackal@bioisred.com
Status Recruiting
Phase Phase 4
Start date April 2015
Completion date June 2015
View Details
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