MedTrace Logo

Brivaracetam Bioequivalence Assessment

NCT07800533 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2026-09-02

No results posted yet for this study

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.

Conditions

  • Bioequivalence Study in Healthy Subjects

Interventions

DRUG

Briveka ® 100 mg

Brivaracetam coated tablets

DRUG

Briviact® 100 mg

Brivaracetam coated tablets

Sponsors & Collaborators

  • Zodiac Produtos Farmaceuticos S.A.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2024-08-09
Primary Completion
2024-08-16
Completion
2024-08-19

Countries

  • Brazil

Study Locations

More Related Trials

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 NCT07800533 on ClinicalTrials.gov