Clinical Research Directory
Browse clinical research sites, groups, and studies.
Bioequivalence Study of Two Brivaracetam Oral Solutions in Healthy Adults Under Fasting and High-Fat Meal Conditions
Sponsor: Jiangsu Chia Tai Fenghai Pharmaceutical Co., Ltd.
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - 55 Years
Study Type
INTERVENTIONAL
Enrollment
60
Start Date
2024-10-21
Completion Date
2024-12-31
Last Updated
2025-01-08
Healthy Volunteers
Yes
Conditions
Interventions
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.
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.
Locations (1)
Nanjing Drum Tower Hospital Affiliated to Nanjing University Medical School
Nanjing, Jiangsu, China