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

NCT06762743 | Enrolling By Invitation Phase 1 DMC

• 1 other identifier: 240605-BLXT-HBE
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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. 1.Do the test and reference formulations of Brivaracetam oral solution exhibit similar pharmacokinetic behavior in the body?
2. 2.What are the clinical safety outcomes for participants taking the test and reference formulations?

Conditions

Epilepsy (treatment Refractory)

Keywords

crossover; bioequivalence; Brivaracetam Oral Solution

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  two weeks

Secondary Outcomes (4)

• Time to Reach Maximum Plasma Concentration(Tmax )

  two weeks

• Terminal Elimination Rate Constant (λz)

  two weeks

• Half-life (t1/2)

  two weeks

• Percentage of the Area Under the Curve Extrapolated to Infinity(AUC_%Extrap )

  two weeks

Study Arms (2)

Fasting group

EXPERIMENTAL

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); Drug: Brivaracetam Oral Solution (Reference Formulation)

High-fat meal group

EXPERIMENTAL

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); Drug: Brivaracetam Oral Solution (Reference Formulation)

Interventions

Brivaracetam Oral Solution (Test Formulation) DRUG

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.

Fasting group; High-fat meal group

Brivaracetam Oral Solution (Reference Formulation) DRUG

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.

Also known as: Briviact®

Fasting group; High-fat meal group

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Jiangsu Chia Tai Fenghai Pharmaceutical Co., Ltd.: lead
• The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School: collaborator

Study Sites (1)

Nanjing Drum Tower Hospital Affiliated to Nanjing University Medical School

Nanjing, Jiangsu, 210033, China

Location

Related Publications (5)

• Velazquez J, Acosta J, Herrera N, Morales A, Gonzalez O, Herrera F, Estrada MP, Carpio Y. Novel IFNgamma homologue identified in Nile tilapia (Oreochromis niloticus) links with immune response in gills under different stimuli. Fish Shellfish Immunol. 2017 Dec;71:275-285. doi: 10.1016/j.fsi.2017.10.014. Epub 2017 Oct 7.

  PMID: 29017941 BACKGROUND

• Aranake A, Mashour GA, Avidan MS. Minimum alveolar concentration: ongoing relevance and clinical utility. Anaesthesia. 2013 May;68(5):512-22. doi: 10.1111/anae.12168. Epub 2013 Feb 16.

  PMID: 23414556 BACKGROUND

• Cho SY, Kwon YK, Nam M, Vaidya B, Kim SR, Lee S, Kwon J, Kim D, Hwang GS. Integrated profiling of global metabolomic and transcriptomic responses to viral hemorrhagic septicemia virus infection in olive flounder. Fish Shellfish Immunol. 2017 Dec;71:220-229. doi: 10.1016/j.fsi.2017.10.007. Epub 2017 Oct 7.

  PMID: 29017947 BACKGROUND

• Tsilidis KK, Panagiotou OA, Sena ES, Aretouli E, Evangelou E, Howells DW, Al-Shahi Salman R, Macleod MR, Ioannidis JP. Evaluation of excess significance bias in animal studies of neurological diseases. PLoS Biol. 2013 Jul;11(7):e1001609. doi: 10.1371/journal.pbio.1001609. Epub 2013 Jul 16.

  PMID: 23874156 BACKGROUND

• Zhu M, Tao Y, Pu J, Zhao H, Wan L, Zhang P, Tang C. Pharmacokinetics and Bioequivalence of Fudosteine in Healthy Chinese Volunteers Under Fasting and Fed Conditions: A 4-Way Replicate Crossover Study. Clin Pharmacol Drug Dev. 2023 Jan;12(1):30-37. doi: 10.1002/cpdd.1137. Epub 2022 Jul 6.

  PMID: 35794358 BACKGROUND

Related Links

• the protocol of the study

MeSH Terms

Conditions

Epilepsy

Interventions

brivaracetam

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This is an open-label study; all participants and investigators are aware of the treatment assignments.
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A two-period, two-sequence crossover design where participants are randomly assigned to receive either the test or reference formulation in a fasted or fed state, with a washout period of seven days between treatments.

Study Record Dates

• First Submitted: December 23, 2024
• First Posted: January 8, 2025
• Study Start: October 21, 2024
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: January 8, 2025

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• 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.
• 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.

Locations

CN (1)