2023-504132-18-00
Completed
Phase 1
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.
Laboratorios Cinfa S.A.1 site in 1 country36 target enrollmentStarted: May 4, 2023Last updated:
Overview
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Laboratorios Cinfa S.A.
- Enrollment
- 36
- Locations
- 1
Overview
Brief Summary
No summary available.
Eligibility Criteria
- Ages
- 18 years to 64 years (18-64 Years)
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Investigators
Manuel Vaz
Scientific
Laboratorios Cinfa S.A.
Study Sites (1)
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