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

NCT05265247 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 61

Last updated 2024-02-05

Study results available
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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.

Conditions

  • Gastrointestinal Diseases

Interventions

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.

Sponsors & Collaborators

  • HALEON

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-03-02
Primary Completion
2022-06-02
Completion
2022-06-02

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05265247 on ClinicalTrials.gov