NCT06762743

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

A Randomized, Open-Label, Two-Formulation, Two-Period, Crossover Bioequivalence Study of Oral Brivaracetam Solution Administered As a Single Dose Under Fasting and High-fat Meal Conditions in Healthy Subjects

• Status: Enrolling By Invitation
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Jiangsu Chia Tai Fenghai Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Epilepsy (treatment Refractory)

Interventions

Type	Name	Description
DRUG	Brivaracetam Oral Solution (Test Formulation)	The drug is manufactured by Jiangsu Chia Tai Fenghai Pharmaceutical Co., Ltd. The formulation is provided as a 300 mL: 3 g solution, with a dosage of 10 mL (100 mg) per single oral dose. The drug will be administered to participants in the fasting group during the first phase of the study and to participants in the high-fat meal group during the second phase of the study.
DRUG	Brivaracetam Oral Solution (Reference Formulation)	The drug is manufactured by UCB Pharma S.A. under the trade name Briviact®. The formulation is provided as a 300 mL: 3 g solution, with a dosage of 10 mL (100 mg) per single oral dose. The drug will be administered to participants in the fasting group during the first phase of the study and to participants in the high-fat meal group during the second phase of the study.

Timeline

• Start date: 2024-10-21
• Primary completion: 2024-12-31
• Completion: 2024-12-31
• First posted: 2025-01-08
• Last updated: 2025-01-08

Locations

1 site across 1 country: China