Trials / Completed
CompletedNCT05038969
Bioequivalence Study of Esomeprazole From Stomopral 40 mg Capsules Contain Enteric Coated Pellets (Future Pharmaceuticals Industries, Egypt) and Nexium 40 mg Delayed Release Capsules (AstraZeneca Sweden, Product of France)
Comparative Randomized, Single Dose,Two-way Crossover Bioequivalence Study to Determine the Bioequivalence of Esomeprazole From Stomopral 40 mg Capsules Contain Enteric Coated Pellets (Future Pharmaceuticals Industries, Egypt) and Nexium 40 mg Delayed Release Capsules (AstraZeneca Sweden, Product of France)
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 30 (actual)
- Sponsor
- Genuine Research Center, Egypt · Industry
- Sex
- All
- Age
- 18 Years – 55 Years
- Healthy volunteers
- Accepted
Summary
Comparative randomized, single dose Bioequivalence Study of Esomeprazole From Stomopral 40 mg Capsules Contain Enteric Coated Pellets (Future Pharmaceuticals Industries, Egypt) and Nexium 40 mg Delayed Release Capsules (AstraZeneca Sweden, Product of France) in Healthy Human Volunteers Under Fasting Condition.
Detailed description
Healthy volunteers, 18-55 years of age, selected from the Egyptian population fulfilling the selection criteria. Minimum of 24 subjects will participate in the study. All dosed subject samples will be analyzed and their data will be included in the final study report. Primary Pharmacokinetic Parameters: Cmax, AUC0→t and AUC0→∞ Secondary Pharmacokinetic Parameters: Ke, tmax and t1/2e. ANOVA using 5% significance level for transformed (with the 90% confidence intervals) and untransformed data of Cmax, AUC0-72 and AUC0-∞ for untransformed data of Ke, tmax and t1/2e. The confidence intervals of logarithmically transformed Test/Reference ratios for Cmax, AUC0-72 and AUC0-∞ to be within 80.00-125.00%. A comprehensive final report will be issued upon the completion of the study.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Stomopral | 1 capsule contains 40 mg Esomeprazole |
| DRUG | Nexium | 1 capsule contains 40 mg Esomeprazole |
Timeline
- Start date
- 2021-03-18
- Primary completion
- 2021-04-01
- Completion
- 2021-05-28
- First posted
- 2021-09-09
- Last updated
- 2021-09-09
Locations
1 site across 1 country: Egypt
Source: ClinicalTrials.gov record NCT05038969. Inclusion in this directory is not an endorsement.