Phase 1
Completed N=64
A Study to Assess the Bioequivalence Between Brivaracetam Tablet and Dry Syrup in Healthy Japanese Male Study Participants
Healthy Study Participants
Source: ClinicalTrials.gov NCT06312566 ↗
Enrolled (actual)
64
Serious AEs
0.0%
Results posted
Jun 2025
Primary outcomePrimary: Maximum Plasma Concentration at Steady State [Cmax(ss)] After Multiple Doses of Brivaracetam — 2.963; 2.878 microgram per milliliter (μg/mL)
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Plasma Concentration at Steady State [Cmax(ss)] After Multiple Doses of Brivaracetam |
2.963; 2.878 | — |
| PRIMARY Area Under the Curve During a Dosing Interval at Steady State [AUC(Tau)] After Multiple Doses of Brivaracetam |
18.55; 18.53 | — |
| SECONDARY Percentage of Study Participants With Treatment-emergent Adverse Events (TEAEs) |
4.8; 10.9 | — |
| SECONDARY Percentage of Study Participants With Treatment-emergent Serious Adverse Events (TESAEs) |
0; 0 | — |
| SECONDARY Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) Leading to Discontinuation |
0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Participant must be between 20 to 50 years of age (inclusive) at the time of signing the informed consent form (ICF)
- Participant is of Japanese descent as evidenced by appearance and verbal confirmation of familial heritage (ie, participant has all 4 Japanese grandparents born in Japan)
- Participant is male
Exclusion Criteria
- Participant has a known hypersensitivity to any components of the investigational medicinal product (IMP) formulations
- Participant has participated in another study of an IMP (and/or an investigational device) within the previous 30 days or within 5 times the half-life (whichever is longer) of the first dose of BRV in this study or is currently participating in another study of an IMP (and/or an investigational device)
- Participant tests positive for alcohol and/or prohibited concomitant drugs (including cotinine) at the Screening Visit or on Day-1
- Participant has donated blood or plasma or has experienced blood loss ≥400 mL within 90 days, ≥200 mL within 30 days, or has donated any blood or plasma within 14 days before first administration of IMP
- Participant is a current smoker or has used nicotine-containing products (eg, tobacco, patches, gum) within 30 days before the first administration of IMP
Data sourced from ClinicalTrials.gov (NCT06312566). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.