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

January 6, 2025 updated by: Jiangsu Chia Tai Fenghai Pharmaceutical Co., Ltd.

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

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 Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210033
        • Nanjing Drum Tower Hospital Affiliated to Nanjing University Medical School

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Age and Gender: Healthy male and female participants aged 18-55 years (inclusive).
  • Weight and BMI: Male participants must weigh ≥50 kg, and females ≥45 kg, with a body mass index (BMI) between 19 and 26. BMI is calculated as: BMI = weight (kg) / height (m²).
  • Participants must fully understand the purpose, methods, content, and test drugs of this study before enrollment, be capable of good communication with investigators, adhere to study requirements, and voluntarily sign the informed consent form.
  • Participants must commit to avoiding pregnancy and refraining from sperm/egg donation from the time of consent through 3 months after the last dose. Participants must agree to use effective contraception (non-pharmacological methods) during the trial. Female participants must have had no unprotected sexual activity within 14 days before the first dose.

Exclusion Criteria:

  • History of allergies (e.g., angioedema, anaphylactic shock) or hypersensitivity (e.g., to pollen, two or more drugs/foods), or known allergy to briciclib or its excipients.
  • Past or current illnesses that may affect drug absorption, distribution, metabolism, excretion, or the interpretation of safety data, or conditions reducing compliance, including but not limited to gastrointestinal, renal, hepatic, pulmonary, neurological, hematological, endocrine, oncological, immunological, psychiatric, or cardiovascular diseases, as judged by the investigator.
  • Major surgery within 3 months prior to screening or planned surgery during the study period, including procedures affecting pharmacokinetics (e.g., gallbladder/biliary tract surgery).
  • History of significant bleeding, active bleeding, thrombocytopenia, coagulation disorders, or family history of coagulopathy.
  • Vaccination within 28 days prior to screening or planned vaccination during the study.
  • History of substance abuse or dependence within the past 5 years or use of drugs such as morphine, methamphetamine, ketamine, cannabis, or ecstasy within 6 months before screening. Positive urine drug screen results are also exclusionary.
  • Difficulty with venipuncture, intolerance to venous puncture, or history of needle or blood phobia.
  • Lactose intolerance.
  • Special dietary requirements that cannot align with standardized study diets.
  • Participation in any clinical trial and drug administration within 3 months prior to screening.
  • Blood donation or significant blood loss (≥400 mL) within 3 months prior to screening (excluding physiological blood loss in women) or intention to donate blood during the study.
  • Regular smokers (≥5 cigarettes/day) or habitual betel nut chewers within 3 months prior to screening, or inability to abstain from tobacco products during the study.
  • Frequent alcohol consumption (more than 14 units per week, where 1 unit = 360 mL beer, 45 mL spirits, or 150 mL wine) within 3 months prior to screening, positive breath alcohol test, or inability to abstain from alcohol during the study.
  • Excessive intake of tea, coffee, caffeine-containing products, grapefruit, or xanthine-rich foods or beverages (e.g., theophylline, caffeine, theobromine) averaging more than 8 cups/day (1 cup = 200 mL) within 3 months prior to screening or inability to discontinue such intake during the study.
  • Use of any medications, including prescription, over-the-counter drugs, herbal medicines, or health supplements, within 14 days prior to the first dose.
  • Use of any liver enzyme-altering drugs within 28 days prior to the first dose.
  • Pregnant or lactating women, or females with positive pregnancy tests.
  • Positive results for any of the following virological tests: Hepatitis B surface antigen, Hepatitis C antibody, HIV antibody, or syphilis antibody.
  • Clinically significant abnormalities in physical examination, vital signs, 12-lead ECG, or laboratory tests at screening, as determined by the investigator.
  • Other reasons that may prevent the participant from completing the study, or any other factors deemed unsuitable for participation by the investigator.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Fasting group
Participants in fasting group will first receive a single oral dose of the test formulation of Brivaracetam oral solution in the first period, followed by a washout period, and then a single oral dose of the reference formulation of Brivaracetam oral solution in the second period.
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.
Other Names:
  • Briviact®
Experimental: High-fat meal group
Participants will first receive a single oral dose of the reference formulation of Brivaracetam oral solution in the first period, followed by a washout period, and then a single oral dose of the test formulation of Brivaracetam in the second period.
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.
Other Names:
  • Briviact®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximum Plasma Concentration (Cmax)
Time Frame: two weeks
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.
two weeks
Area Under the Plasma Concentration-Time Curve from Time 0 to Last Measurable Concentration (AUC0-t)
Time Frame: two weeks
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.
two weeks
Area Under the Plasma Concentration-Time Curve from Time 0 to Infinity (AUC0-∞)
Time Frame: two weeks
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.
two weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to Reach Maximum Plasma Concentration(Tmax )
Time Frame: two weeks
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.
two weeks
Terminal Elimination Rate Constant (λz)
Time Frame: two weeks
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.
two weeks
Half-life (t1/2)
Time Frame: two weeks
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.
two weeks
Percentage of the Area Under the Curve Extrapolated to Infinity(AUC_%Extrap )
Time Frame: two weeks
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.
two weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jiangsu Chia Tai Fenghai Pharmaceutical Co., Ltd.

Collaborators

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 21, 2024

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

December 23, 2024

First Submitted That Met QC Criteria

January 6, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 6, 2025

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 240605-BLXT-HBE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Time Frame

Start Date: IPD and supporting information will be available starting from the publication of the primary study results.

End Date: IPD and supporting information will be available for a period of five years following the study's completion and publication. After this period, access may be restricted or subject to specific conditions.

IPD Sharing Access Criteria

Qualified researchers, including academic institutions, non-profit organizations, and industry collaborators, will be able to access the de-identified individual participant data (IPD), provided they meet the necessary data use requirements.

The available IPD will include the de-identified clinical and laboratory data collected throughout the study, such as demographic information, baseline clinical characteristics, treatment regimens, and efficacy and safety outcomes, including adverse events, pharmacokinetic data, and biomarker analyses.

Data will be made available upon request through https://clinicalstudydatarequest.com/. Researchers wishing to access the data must submit a formal request, which will be evaluated based on the study's data sharing policies and relevant data use agreements.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Study Data/Documents

  1. Study Protocol
    Information comments: registered clinical trial about Brivaracetam oral solution on Chinese website

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Epilepsy (treatment Refractory)

Clinical Trials on Brivaracetam Oral Solution (Test Formulation)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Angola

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe