Phase 1
Completed N=24
A Study to Assess the Bioequivalence Between Brivaracetam Tablet and Dry Syrup in Healthy Male Japanese Study Participants
Healthy Study Participants
Source: ClinicalTrials.gov NCT05315947 ↗
Enrolled (actual)
24
Serious AEs
0.0%
Results posted
Jan 2024
Primary outcomePrimary: Maximum Plasma Concentration (Cmax) for a Single Dose of Brivaracetam — 2.286; 1.989 micrograms per milliliter (μg/mL)
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Plasma Concentration (Cmax) for a Single Dose of Brivaracetam |
2.286; 1.989 | — |
| PRIMARY Area Under the Curve From 0 to the Time of the Last Quantifiable Concentration (AUC(0-t)) for a Single Dose of Brivaracetam |
17.98; 17.78 | — |
| SECONDARY Percentage of Participants With at Least One Treatment-emergent Adverse Event (TEAE) |
37.5; 37.5 | — |
| SECONDARY Percentage of Participants With at Least One Treatment-emergent Serious Adverse Event (SAE) |
0; 0 | — |
Eligibility Criteria
Inclusion criteria
- Study participant must be between 20 to 50 years of age (inclusive) at the time of signing the Informed Consent Form (ICF)
- Study participant is overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring
- Study participant is of Japanese descent as evidenced by appearance and verbal confirmation of familial heritage (a study participant has all 4 Japanese grandparents born in Japan)
Exclusion criteria
- Study participant has used other drugs, including over-the-counter medications, herbal/traditional medicines, or dietary supplements (excluding medicines for external use),with the exception of paracetamol, within 14 days before first administration of IMP or has received a coronavirus disease 2019 (COVID-19) vaccine within 7 days of initiating IMP
- Study participant has used hepatic enzyme-inducing drugs (eg, glucocorticoids, phenobarbital, isoniazid, phenytoin, rifampicin) within 2 months before the first administration of Investigational Medicinal Product (IMP)
- Study participant has a positive result for hepatitis B surface antigen, hepatitis C virus antibody test, human immunodeficiency virus antibody test, or syphilis at Screening Visit
- Study 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
- Study participant is a current smoker or has used nicotine-containing products (eg, tobacco, patches, gum) within 30 days before the first administration of IMP
- Consumption of more than 600 mg of caffeine/day (1 cup of coffee contains approximately 100mg of caffeine, 1 cup of tea approximately 30 mg, and 1 glass of cola approximately 20 mg)
Data sourced from ClinicalTrials.gov (NCT05315947). 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.