Single dose, open-label, laboratory blinded, randomised, 2-treatment, 2-period, 2-sequence, crossover bioequivalence study of test product Perampanel 12 mg film-coated tablets versus reference product Fycompa 12 mg film-coated tablets (Eisai GmbH) in healthy adult male and female subjects under fasting conditions.

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-503345-59-00

Acronym

CFA-1031-1-22

Enrollment

Registered

2023-05-04

Start date

2023-05-23

Completion date

2023-08-15

Last updated

2023-05-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Not applicable (submitted trial is a bioequivalence study in Healthy Subjects)

None listed

Sex/Gender

All

Age

18 Years to 64 Years

Czechia

None listed

Source: EU CTIS · Data processed: Feb 4, 2026