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Brivaracetam Bioequivalence Assessment
Sponsor: Zodiac Produtos Farmaceuticos S.A.
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
Conditions
Interventions
Briveka ® 100 mg
Brivaracetam coated tablets
Briviact® 100 mg
Brivaracetam coated tablets
Locations (1)
Unidade Integrada de Farmacologia e Gastroenterologia (UNIFAG)
Bragança Paulista, São Paulo, Brazil