At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 61 enrolled
Drug / intervention
Esomeprazole 20 mg Delayed-Release Capsules +1 moredrug
Likely dose
Esomeprazole 20 mg Delayed-Release Capsulesfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 1 clinical trial evaluating Esomeprazole 20 mg Delayed-Release Capsules and Esomeprazole 20 mg Delayed-Release Capsules (Nexium 24HR) for Gastrointestinal Diseases. Completed, enrolled 61 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGastrointestinal Diseases
CountriesCanada
Collaborators--
Timeline
Phase 1CompletedFinished
2023202420252026
Enrollment StartMar 2022
First PostedMar 2022
Primary CompletionJun 2022
TodayJul 2026
First PostedMar 3, 2022
Enrollment StartMar 2, 2022
Primary CompletionJun 2, 2022
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 4.3 years ago
Interventions
Esomeprazole 20 mg Delayed-Release Capsulesdrug
Esomeprazole 20 mg delayed-release capsules will be given as one capsule once daily as oral administration.
Esomeprazole 20 mg Delayed-Release Capsules (Nexium 24HR)drug
Esomeprazole 20 mg delayed-release capsules (Nexium 24HR) will be given as one capsule once daily as oral administration.