At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 24 enrolled
Drug / intervention
brivaracetam +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Single-Dose, Open-Label, Randomized, 2-Way Cross-Over Study to Assess the Bioequivalence Between Brivaracetam Tablet and Dry Syrup in Healthy Male Japanese Study Participants
In Brief
A Phase 1 clinical trial evaluating brivaracetam for Healthy Study Participants. Completed, enrolled 24 participants across 1 site.
Detailed Summary
The purpose of the study is to demonstrate the bioequivalence between the BRV tablet and BRV as dry syrup after a single oral dose in healthy Japanese male study participants.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy Study Participants
CountriesJapan
Collaborators--
Timeline
Phase 1CompletedFinished
2023202420252026
Enrollment StartApr 2022
First PostedApr 2022
Primary CompletionMay 2022
TodayJul 2026
First PostedApr 7, 2022
Enrollment StartApr 4, 2022
Primary CompletionMay 13, 2022
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 4.2 years ago
Interventions
brivaracetamdrug
Study participants will receive a single-dose of brivaractam tablet (reference - Treatment A) administered orally.
brivaracetamdrug
Study participants will receive a single-dose of brivaractam dry syrup (test - Treatment B) administered orally.