NCT05265247

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 61 (actual)
• Sponsor: HALEON · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Gastrointestinal Diseases

Interventions

Type	Name	Description
DRUG	Esomeprazole 20 mg Delayed-Release Capsules	Esomeprazole 20 mg delayed-release capsules will be given as one capsule once daily as oral administration.
DRUG	Esomeprazole 20 mg Delayed-Release Capsules (Nexium 24HR)	Esomeprazole 20 mg delayed-release capsules (Nexium 24HR) will be given as one capsule once daily as oral administration.

Timeline

• Start date: 2022-03-02
• Primary completion: 2022-06-02
• Completion: 2022-06-02
• First posted: 2022-03-03
• Last updated: 2024-02-05
• Results posted: 2024-02-05

Locations

1 site across 1 country: Canada