NCT06312566

A Study to Assess the Bioequivalence Between Brivaracetam Tablet and Dry Syrup in Healthy Japanese Male Study Participants

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: UCB Biopharma SRL · Industry
• Sex: Male
• Age: 20 Years – 50 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy Study Participants

Interventions

Type	Name	Description
DRUG	brivaracetam (BRV) tablet	Study participants will receive multiple-doses of brivaracetam tablet (reference - Treatment A) administered orally.
DRUG	brivaracetam (BRV) dry syrup	Study participants will receive multiple-doses of brivaracetam dry syrup (test - Treatment B) administered orally.

Timeline

• Start date: 2024-03-25
• Primary completion: 2024-06-04
• Completion: 2024-06-04
• First posted: 2024-03-15
• Last updated: 2025-06-06
• Results posted: 2025-06-06

Locations

1 site across 1 country: Japan