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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
52
Esomeprazole Capsule
Esomeprazole Tablet
Pharmaceutical Research Associates, Inc.
Lenexa, Kansas, United States
AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Esomeprazole
Time frame: Day 1 pre-dose and at multiple time points (up to 10 hours) post-dose
AUCt: Area Under the Plasma Concentration-time Curve From Time 0 to Time t for Esomeprazole
Time frame: Day 1 pre-dose and at multiple time points (up to 10 hours) post-dose
Cmax: Maximum Observed Plasma Concentration for Esomeprazole
Time frame: Day 1 pre-dose and at multiple time points (up to 10 hours) post-dose
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