NCT06450223

Bioequivalence Study of Perampanel Tablets 12 mg

An Open-label, Balanced, Randomized, Two Treatment, Two Sequence, Two Period, Two Way Cross-over, Single Dose Bioequivalence Study of Perampanel Tablets 12 mg of Humanis Sağlık A.Ş., Turkey and Fycompa 12 mg Film-coated Tablets of Eisai GmbH Edmund-Rumpler-Straße 3 60549 Frankfurt am Main Germany in Normal, Healthy, Adult, Human Subjects Under Fasting Condition

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Humanis Saglık Anonim Sirketi · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

An open-label, balanced, randomized, two treatment, two sequence, two period, two way cross-over, single dose bioequivalence study of Perampanel Tablets 12 mg of Humanis Sağlık A.ġ., Turkey and Fycompa 12 mg film-coated tablets of Eisai GmbH Edmund-Rumpler-Straße 3 60549 Frankfurt am Main Germany in normal, healthy, adult, human subjects under fasting condition.

Conditions

• Epilepsy

Interventions

Type	Name	Description
DRUG	Perampanel 12 MG	1 tablet of Perampanel Tablets 12 mg
DRUG	Fycompa 12 mg film-coated tablets	1 tablet of Perampanel Tablets 12 mg

Timeline

• Start date: 2023-09-14
• Primary completion: 2023-09-20
• Completion: 2023-12-05
• First posted: 2024-06-10
• Last updated: 2024-06-12

Locations

1 site across 1 country: India