Trials / Completed
CompletedNCT05855187
Bioequivalence Study of Modafinil From Bravamax 200 mg Scored Tablets (Chemipharm Pharmaceutical Industries, Egypt) Versus Vigil 200 mg Tablets (Teva GmbH, Germany)
Comparative Randomized, Single Dose, Two-way Crossover Bioequivalence Study to Determine the Bioequivalence of Modafinil From Bravamax 200 mg Scored Tablets (Chemipharm Pharmaceutical Industries, Egypt) Versus Vigil 200 mg Tablets (Teva GmbH, Germany)
- 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, Two-way Crossover Bioequivalence Study to determine the bioequivalence of Modafinil From Bravamax 200 mg Scored Tablets (Chemipharm Pharmaceutical Industries, Egypt) Versus Vigil 200 mg Tablets (Teva GmbH, Germany)
Detailed description
Healthy volunteers, 18-55 years of age, selected from the Egyptian population fulfilling the selection criteria. 24 healthy 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 log transformed (with the 90% confidence intervals) and untransformed data of Cmax,, AUC0→t and AUC0→∞and for untransformed data of Ke, tmax and t1/2e. The confidence intervals of logarithmically transformed Test/Reference ratios for AUC0→t, AUC0→∞and Cmax 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 | Bravamax 200 mg (Modafinil) | Test drug |
| DRUG | Vigil 200 mg (Modafinil) | Reference drug |
Timeline
- Start date
- 2022-11-15
- Primary completion
- 2022-11-22
- Completion
- 2023-01-10
- First posted
- 2023-05-11
- Last updated
- 2023-05-11
Locations
1 site across 1 country: Egypt
Source: ClinicalTrials.gov record NCT05855187. Inclusion in this directory is not an endorsement.