At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 64 enrolled
Drug / intervention
brivaracetam (BRV) tablet +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 Multiple-Dose, Open-Label, Randomized, 2-Way Cross-Over Study to Assess the Bioequivalence Between Brivaracetam Tablet and Dry Syrup in Healthy Male Japanese Participants
In Brief
A Phase 1 clinical trial evaluating brivaracetam (BRV) tablet and brivaracetam (BRV) dry syrup for Healthy Study Participants. Completed, enrolled 64 participants across 1 site.
Detailed Summary
The purpose of the study is to demonstrate the bioequivalence between the BRV tablet and BRV dry syrup after multiple oral doses in healthy male Japanese participants.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy Study Participants
CountriesJapan
Collaborators--
Timeline
Phase 1CompletedFinished
20252026
First PostedMar 2024
Enrollment StartMar 2024
Primary CompletionJun 2024
TodayJul 2026
First PostedMar 15, 2024
Enrollment StartMar 25, 2024
Primary CompletionJun 4, 2024
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 2.3 years ago
Interventions
brivaracetam (BRV) tabletdrug
Study participants will receive multiple-doses of brivaracetam tablet (reference - Treatment A) administered orally.
brivaracetam (BRV) dry syrupdrug
Study participants will receive multiple-doses of brivaracetam dry syrup (test - Treatment B) administered orally.