NCT05315947

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (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 as dry syrup after a single oral dose in healthy Japanese male study participants.

Conditions

• Healthy Study Participants

Interventions

Type	Name	Description
DRUG	brivaracetam	Study participants will receive a single-dose of brivaractam tablet (reference - Treatment A) administered orally.
DRUG	brivaracetam	Study participants will receive a single-dose of brivaractam dry syrup (test - Treatment B) administered orally.

Timeline

• Start date: 2022-04-04
• Primary completion: 2022-05-13
• Completion: 2022-05-13
• First posted: 2022-04-07
• Last updated: 2024-01-05
• Results posted: 2024-01-05

Locations

1 site across 1 country: Japan