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Bioequivalence Study of Perampanel Tablets 12 mg

NCT06450223 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2024-06-12

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Humanis Saglık Anonim Sirketi

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-09-14
Primary Completion
2023-09-20
Completion
2023-12-05

Countries

  • India

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06450223 on ClinicalTrials.gov