Brivaracetam Bioequivalence Assessment

NCT07800533 | Completed Phase 1

• 1 other identifier: CNSP2024
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

This study assess the relative bioavailability performance of a test brivaracetam coated tablets compared with the EMA reference product, Briviact® 100 mg, in healthy adult volunteers of both sexes under fasting conditions. The pharmacokinetic profiles will be compared to assess whether the test product demonstrates equivalent rate and extent of absorption to the reference formulation.

Conditions

Bioequivalence Study in Healthy Subjects

Outcome Measures

Primary Outcomes (2)

• Cmax

  Maximum observed plasma concentration of brivaracetam following a single-dose.

  Up to 48 hours after drug administration

• AUC0-t

  Area under the plasma concentration-time curve from time zero to the last quantifiable concentration of brivaracetam.

  Up to 48 hours after drug administration

Study Arms (2)

Test

EXPERIMENTAL

Single oral dose administration of the test formulation Briveka® (brivaracetam coated tablets) 100 mg

Drug: Briveka ® 100 mg

Comparator

ACTIVE COMPARATOR

Single oral dose administration of the reference formulation Briviact® (brivaracetam coated tablets) 100 mg

Drug: Briviact® 100 mg

Interventions

Briveka ® 100 mg DRUG

Brivaracetam coated tablets

Also known as: Test

Test

Briviact® 100 mg DRUG

Brivaracetam coated tablets

Also known as: Comparator

Comparator

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Body mass index (BMI) between 18.5 and 30.0 kg/m². Non-smokers or former smokers who stopped smoking at least 1 year prior to screening.
• Clinically healthy based on medical history, physical examination, vital signs, ECG, and clinical laboratory tests.
• Negative screening for HIV, hepatitis B, and hepatitis C. Female participants must not be pregnant or breastfeeding and must have a negative pregnancy test.
• No hair, wounds, or dermatological conditions at the intended patch application site (upper arm).
• Able to understand the study procedures and provide written informed consent

You may not qualify if:

• History or presence of clinically significant cardiovascular, hepatic, renal, gastrointestinal, neurological, psychiatric, metabolic, pulmonary, or dermatological diseases.
• Known hypersensitivity to rivastigmine, carbamate derivatives, or any component of the study formulation.
• Abnormal clinical laboratory results, vital signs, or ECG considered clinically significant by the investigator.
• Positive test results for drugs of abuse, alcohol misuse, HIV, hepatitis B, or hepatitis C.
• Use of prescription or non-prescription medications that could interfere with the study drug within a defined period prior to dosing, as determined by the investigator.
• Participation in another clinical trial or exposure to an investigational drug within the previous 6 months.
• Blood donation or significant blood loss within 3 months prior to the study.
• Consumption of grapefruit-containing products, alcohol, or substances that could interfere with drug metabolism prior to dosing.
• Use of medications known to significantly affect hepatic metabolism.
• Positive or suspected infection with SARS-CoV-2 prior to study periods.
• Any condition that, in the investigator's judgment, could interfere with study participation or the interpretation of study results.

Sponsors & Collaborators

• Zodiac Produtos Farmaceuticos S.A.: lead

Study Sites (1)

Unidade Integrada de Farmacologia e Gastroenterologia (UNIFAG)

Bragança Paulista, São Paulo, 12916-900, Brazil

Location

Related Publications (3)

• Van Paesschen W, Hirsch E, Johnson M, Falter U, von Rosenstiel P. Efficacy and tolerability of adjunctive brivaracetam in adults with uncontrolled partial-onset seizures: a phase IIb, randomized, controlled trial. Epilepsia. 2013 Jan;54(1):89-97. doi: 10.1111/j.1528-1167.2012.03598.x. Epub 2012 Jul 19.

  PMID: 22813235 BACKGROUND

• Sargentini-Maier ML, Rolan P, Connell J, Tytgat D, Jacobs T, Pigeolet E, Riethuisen JM, Stockis A. The pharmacokinetics, CNS pharmacodynamics and adverse event profile of brivaracetam after single increasing oral doses in healthy males. Br J Clin Pharmacol. 2007 Jun;63(6):680-8. doi: 10.1111/j.1365-2125.2006.02829.x. Epub 2007 Jan 12.

  PMID: 17223857 BACKGROUND

• Otoul C, Watanabe S, McCabe S, Stockis A. Relative Bioavailability and Bioequivalence of Brivaracetam 10 mg/mL Oral Solution and 50-mg Film-Coated Tablet. Clin Pharmacol Drug Dev. 2017 May;6(3):313-317. doi: 10.1002/cpdd.275. Epub 2016 Jun 28. No abstract available.

  PMID: 27274002 BACKGROUND

MeSH Terms

Interventions

brivaracetam

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2026
• First Posted: September 2, 2026
• Study Start: August 9, 2024
• Primary Completion: August 16, 2024
• Study Completion: August 19, 2024
• Last Updated: September 2, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)