A Phase 1 interventional study of Bravamax 200 mg (Modafinil) and Vigil 200 mg (Modafinil) in Healthy, sponsored by Genuine Research Center, Egypt. Completed at 1 site in Egypt. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-05-11.
Sponsored by Genuine Research Center, Egypt · Phase 1, Interventional, and Other
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)
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.
Genuine Research Center, Egypt is the lead sponsor of 38 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
1 tablet contains 200 mg Modafinil administrated according to a randomization scheme with 240 ml of water.
Drug: Bravamax 200 mg (Modafinil)
1 tablet contains 200 mg Modafinil administrated according to a randomization scheme with 240 ml of water.
Drug: Vigil 200 mg (Modafinil)
Test drug
Also known as: Vigil
Reference drug
Also known as: Vigil
Cmax
to measure the maximal measured plasma concentration
Time frame: Up to 72 hours post dose in each treatment period
Tmax
time of the maximum plasma concentration
Time frame: Up to 72 hours post dose in each treatment period
Plan to share: No
This study is completed, as verified in May 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Modafinil
Genuine Research Center, Egypt →