Bioequivalence Study of Modafinil From Bravamax 200 mg Scored Tablets (Chemipharm Pharmaceutical Industries, Egypt) Versus Vigil 200 mg Tablets (Teva GmbH, Germany)
NCT05855187 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30
Last updated 2023-05-11
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)
Conditions
- Healthy
Interventions
- DRUG
-
Bravamax 200 mg (Modafinil)
Test drug
- DRUG
-
Vigil 200 mg (Modafinil)
Reference drug
Sponsors & Collaborators
-
Chemipharm Pharmaceutical Industries, Egypt
collaborator UNKNOWN -
Genuine Research Center, Egypt
lead INDUSTRY
Principal Investigators
-
Ahmed Elshafeey, Ph.D. Pharma · Genuine Research Center
Study Design
- Allocation
- RANDOMIZED
- Purpose
- OTHER
- Masking
- NONE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Max Age
- 55 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2022-11-15
- Primary Completion
- 2022-11-22
- Completion
- 2023-01-10
Countries
- Egypt
Study Locations
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