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Bioequivalence Study of Modafinil From Bravamax 200 mg Scored Tablets (Chemipharm Pharmaceutical Industries, Egypt) Versus Vigil 200 mg Tablets (Teva GmbH, Germany)

Healthy Clinical Trial

Official title:
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)

Clinical Trial 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)

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05855187
Study type Interventional
Source Genuine Research Center, Egypt
Contact
Status Completed
Phase Phase 1
Start date November 15, 2022
Completion date January 10, 2023
View Details
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