Bioequivalence Study of Two Brivaracetam Oral Solutions in Healthy Adults Under Fasting and High-Fat Meal Conditions

The goal of this clinical trial is to evaluate the bioequivalence of Brivaracetam oral solution under fasting and high-fat meal conditions in healthy adults. The study will compare a test formulation (produced by Jiangsu Chia Tai Fenghai Pharmaceutical Co., Ltd., 300ml: 3g) to the reference formulation (Briviact®, UCB Pharma S.A., 300ml: 3g). The main questions it aims to answer are: 1. Do the test and reference formulations of Brivaracetam oral solution exhibit similar pharmacokinetic behavior in the body? 2. What are the clinical safety outcomes for participants taking the test and reference formulations? Participants will: Be randomly assigned to two treatment sequences (T-R or R-T) in a 1:1 ratio. Receive either the test formulation or reference formulation of Brivaracetam oral solution (10ml), taken with 240mL of warm water, under either fasting or high-fat meal conditions. Cross over to the alternate formulation after a 7-day washout period, completing a total of two treatment periods (2 weeks). Undergo regular checkups and tests to monitor pharmacokinetics and safety outcomes.

NCT Number	NCT06762743
Lead Sponsor	Jiangsu Chia Tai Fenghai Pharmaceutical Co., Ltd. Collaborators: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Conditions	Epilepsy (treatment Refractory)
Enrollment	60 participants
Start Date	2024-10-21
Primary Completion	2024-12-31 (estimated)
Study Completion	2024-12-31 (estimated)
Updated on ClinicalTrials.gov	2025-01-08