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COMPLETED
NCT07800533
PHASE1

Brivaracetam Bioequivalence Assessment

Sponsor: Zodiac Produtos Farmaceuticos S.A.

View on ClinicalTrials.gov

Summary

This study assess the relative bioavailability performance of a test brivaracetam coated tablets compared with the EMA reference product, Briviact® 100 mg, in healthy adult volunteers of both sexes under fasting conditions. The pharmacokinetic profiles will be compared to assess whether the test product demonstrates equivalent rate and extent of absorption to the reference formulation.

Official title: Bioequivalence Assessment Between Two Brivaracetam 100 mg Coated Tablet Formulations

Key Details

Gender

All

Age Range

18 Years - 50 Years

Study Type

INTERVENTIONAL

Enrollment

28

Start Date

2024-08-09

Completion Date

2024-08-19

Last Updated

2026-09-02

Healthy Volunteers

Yes

Interventions

DRUG

Briveka ® 100 mg

Brivaracetam coated tablets

DRUG

Briviact® 100 mg

Brivaracetam coated tablets

Locations (1)

Unidade Integrada de Farmacologia e Gastroenterologia (UNIFAG)

Bragança Paulista, São Paulo, Brazil