Overview

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

Status:
ENROLLING_BY_INVITATION

Trial end date:
2024-12-31

Target enrollment:

Participant gender:

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.

Phase:

PHASE1

Details

Lead Sponsor:

Jiangsu Chia Tai Fenghai Pharmaceutical Co., Ltd.

Collaborator:

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Treatments:

brivaracetam