clinical trial · NCT06450223
Bioequivalence Study of Perampanel Tablets 12 mg
Humanis Saglık Anonim Sirketi·phase1·completed·n = 30
EpilepsyPerampanel 12 MGFycompa 12 mg film-coated tablets
brief 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.
started
Sep 14, 2023
primary completion
Sep 20, 2023
completion
Dec 5, 2023
last updated
Jun 12, 2024
official title
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
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