Single dose, open-label, laboratory blinded, randomised, 2-treatment, 2-period, 2-sequence, crossover bioequivalence study of test product Perampanel 2 mg film-coated tablets versus reference product Fycompa 2 mg film-coated tablets (Eisai GmbH) in healthy adult male and female subjects under fasting conditions.
Phase 1
- Conditions
- .A. (submitted trial is a bioequivalence study in healthy human subjects)Therapeutic area: Diseases [C] - Nervous System Diseases [C10]MedDRA version: 20.0Level: HLGTClassification code: 10039911Term: Seizures (incl subtypes) Class: 10029205
- Registration Number
- CTIS2023-504132-18-00
- Lead Sponsor
- aboratorios Cinfa S.A.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 36
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: ;Secondary Objective: ;Primary end point(s):
- Secondary Outcome Measures
Name Time Method