NCT03083639

A Study to Evaluate the Bioequivalence of Single Oral Dose of Esomeprazole Capsule and Tablet Formulation in Healthy Participants

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: Takeda · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to determine the bioequivalence of esomeprazole 40 milligram (mg) tablets and capsules.

Detailed description

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.

Conditions

• Healthy Participants

Interventions

Type	Name	Description
DRUG	Esomeprazole Capsule	Esomeprazole Capsule
DRUG	Esomeprazole Tablet	Esomeprazole Tablet

Timeline

• Start date: 2017-03-27
• Primary completion: 2017-05-13
• Completion: 2017-05-13
• First posted: 2017-03-20
• Last updated: 2019-06-14
• Results posted: 2019-06-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study