Healthy Participants Clinical Trial
Official title:
A Phase 1, Randomized, Open-label, 2-way Cross-over Study to Evaluate the Bioequivalence Between a Single Oral Dose of Esomeprazole 40 mg Capsules and Esomeprazole 40 mg Tablets in Healthy Subjects
The purpose of this study is to determine the bioequivalence of esomeprazole 40 milligram (mg) tablets and capsules.
The drug being tested in this study is called esomeprazole. Esomeprazole is being tested in
healthy participants in order to evaluate the bioequivalence between a single oral dose of
esomeprazole tablet and capsule. The study will enroll 52 participants. Participants will be
randomly assigned (by chance, like flipping a coin) to one of the two treatment sequences:
- Esomeprazole 40 mg capsule + Esomeprazole 40 mg tablet
- Esomeprazole 40 mg tablet + Esomeprazole 40 mg capsule
All participants will be asked to take one capsule or tablet on Day 1 of each Intervention
Period based on the treatment sequence to which the participant has been assigned.
This single center trial will be conducted in the United States. The overall duration to
participate in this study is 36 days. Participants will visit the clinic on Day -1 and
remained confined until Day 1 of Intervention Period 1 and 2. A washout period of minimum 6
days will be maintained between the dose in each Intervention Period.
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