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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
60
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.
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.
Nanjing Drum Tower Hospital Affiliated to Nanjing University Medical School
Nanjing, Jiangsu, China
Maximum Plasma Concentration (Cmax)
Cmax is the maximum observed plasma concentration of the drug following a single oral dose. This parameter reflects the peak exposure to the drug in the bloodstream after administration.
Time frame: two weeks
Area Under the Plasma Concentration-Time Curve from Time 0 to Last Measurable Concentration (AUC0-t)
AUC0-t represents the total drug exposure from time 0 to the last measurable concentration. It is an important pharmacokinetic parameter for understanding the extent of drug absorption over time.
Time frame: two weeks
Area Under the Plasma Concentration-Time Curve from Time 0 to Infinity (AUC0-∞)
AUC0-∞ is the area under the plasma concentration-time curve from time 0 to infinity, capturing the total exposure to the drug. It includes all measurable concentrations, both during and after the absorption phase.
Time frame: two weeks
Time to Reach Maximum Plasma Concentration(Tmax )
Tmax is the time it takes to reach the maximum plasma concentration (Cmax) after a single dose of the drug. It indicates the rate at which the drug is absorbed into the bloodstream.
Time frame: two weeks
Terminal Elimination Rate Constant (λz)
λz is the terminal elimination rate constant, which is used to describe the rate at which the drug is cleared from the body during the elimination phase. This value helps estimate the half-life of the drug.
Time frame: two weeks
Half-life (t1/2)
t1/2 is the time required for the plasma concentration of the drug to decrease by half. It is a key pharmacokinetic parameter to understand the duration of action of the drug.
Time frame: two weeks
Percentage of the Area Under the Curve Extrapolated to Infinity(AUC_%Extrap )
AUC\_%Extrap is the percentage of the total AUC that is extrapolated beyond the last measured concentration (AUC∞ - AUC0-t) / AUC∞. This indicates the reliability of the AUC data and how much data is based on extrapolated values.
Time frame: two weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.