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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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)

Conditions
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Healthy

Intervention / Treatment
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* Drug: Bravamax 200 mg (Modafinil)
* Drug: Vigil 200 mg (Modafinil)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male or female, age 18 to 55 years, inclusive. Body weight within 15% of normal range according to the accepted normal values for body mass index (BMI) which is between (18.5-30.0). Medical demographics without evidence of clinically significant deviation from normal medical condition, eg: no history of heart, liver, kidney, gastrointestinal, nervous system, or metabolic abnormalities. Results of clinical laboratory test are within the normal range or with a deviation that is not considered clinically significant by principal investigator. Females should be on a suitable birth control method. Fully informed subjects that consented to participate in the study. Exclusion Criteria: Subjects with known allergy to the products tested. Subjects who meet any of the contraindications to the administration of Modafinil. Subjects that do not agree not to consume alcohol-containing beverages and foods for 48 hours before dosing and throughout the period of sample collection. Heavy smokers. Female subjects who were pregnant or nursing. Acute infection within one week preceding first study drug administration. History of drug or alcohol abuse. Subject does not comply with the stated instruction of not taking any prescription or non-prescription drugs within two weeks before first study drug administration and until the end of the study. Subject is on a special diet (for example subject is vegetarian). Subject does not agree not to consume any beverages or foods containing methyl-xanthenes e.g. caffeine (coffee, tea, cola, chocolate etc.) 48 hours prior to the study administration of either study period until donating the last sample in each respective period. Subject does not agree not to consume any beverages or foods containing grapefruit 14 days prior to first study drug administration until the end of the study. Subject has a family history of severe diseases which have direct impact on the study. Participation in a bioequivalence study or in a clinical study within the last 8 weeks before first study drug administration. Subject intends to be hospitalized within 3 months after first study drug administration. Subjects who have blood donated or lost more than 500 mL blood within 3 months prior to the study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Comparative, Randomized, Single Dose, Two-way Crossover Bioequivalence Study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: T test<br>1 tablet contains 200 mg Modafinil administrated according to a randomization scheme with 240 ml of water. | Drug: Bravamax 200 mg (Modafinil)<br>* Test drug<br>* Other names: Vigil;|
| Active Comparator: R Reference<br>1 tablet contains 200 mg Modafinil administrated according to a randomization scheme with 240 ml of water. | Drug: Vigil 200 mg (Modafinil)<br>* Reference drug<br>* Other names: Vigil;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax | to measure the maximal measured plasma concentration | Up to 72 hours post dose in each treatment period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tmax | time of the maximum plasma concentration | Up to 72 hours post dose in each treatment period |