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Bioequivalence Study of Esomeprazole 20 Milligram (mg) Delayed-Release Capsules in Healthy Adult Participants

Gastrointestinal Diseases Clinical Trial

Official title:
A Randomized, Single Blind, Single Center, Single Dose, Two Period, Two Sequence Crossover Bioequivalence Study of Esomeprazole 20 mg Delayed-Release Capsules (Catalent, Guayama) Compared to the Esomeprazole 20 mg Delayed-Release Capsules ([Nexium 24HR] AstraZeneca Södertälje) in Healthy Adult Subjects Under Fasted Conditions

Clinical Trial Summary

The purpose of this study is to evaluate bioequivalence parameters of esomeprazole capsules 20 mg (test product) vs. esomeprazole capsules 20 mg (reference product) under fasted conditions.

Clinical Trial Description

This will be a single center, single dose, single-blind, randomized, two-sequence, two-period crossover, bioequivalence study in healthy adult participants with at least a 7-day washout period. The study will consist of an ambulant screening day within 28 days prior to first product administration and two study periods. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05265247
Study type Interventional
Source HALEON
Contact
Status Completed
Phase Phase 1
Start date March 2, 2022
Completion date June 2, 2022
View Details
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