A Study to Assess the Bioequivalence Between Brivaracetam Tablet and Dry Syrup in Healthy Japanese Male Study Participants

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-25

Study Completion Date

2024-06-04

Brief Summary

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The purpose of the study is to demonstrate the bioequivalence between the BRV tablet and BRV dry syrup after multiple oral doses in healthy male Japanese participants.

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Detailed Description

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Conditions

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Healthy Study Participants

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Treatment A-B

Study participants randomized to this arm will receive multiple doses of brivaracetam tablet (Treatment A) as reference and multiple doses of brivaracetam dry syrup (Treatment B) as test in the treatment sequence A-B at pre-specified timepoints.

Group Type EXPERIMENTAL

brivaracetam (BRV) tablet

Intervention Type DRUG

Study participants will receive multiple-doses of brivaracetam tablet (reference - Treatment A) administered orally.

brivaracetam (BRV) dry syrup

Intervention Type DRUG

Study participants will receive multiple-doses of brivaracetam dry syrup (test - Treatment B) administered orally.

Treatment B-A

Study participants randomized to this arm will receive multiple doses of brivaracetam tablet (Treatment A) as reference and multiple doses of brivaracetam dry syrup (Treatment B) as test in the treatment sequence B-A at pre-specified timepoints.

Group Type EXPERIMENTAL

brivaracetam (BRV) tablet

Intervention Type DRUG

Study participants will receive multiple-doses of brivaracetam tablet (reference - Treatment A) administered orally.

brivaracetam (BRV) dry syrup

Intervention Type DRUG

Study participants will receive multiple-doses of brivaracetam dry syrup (test - Treatment B) administered orally.

Interventions

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brivaracetam (BRV) tablet

Study participants will receive multiple-doses of brivaracetam tablet (reference - Treatment A) administered orally.

Intervention Type DRUG

brivaracetam (BRV) dry syrup

Study participants will receive multiple-doses of brivaracetam dry syrup (test - Treatment B) administered orally.

Intervention Type DRUG

Other Intervention Names

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BRV Briviact BRV

Eligibility Criteria

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Inclusion Criteria

* Participant must be between 20 to 50 years of age (inclusive) at the time of signing the informed consent form (ICF)
* Participant is of Japanese descent as evidenced by appearance and verbal confirmation of familial heritage (ie, participant has all 4 Japanese grandparents born in Japan)
* Participant is male

Exclusion Criteria

* Participant has a known hypersensitivity to any components of the investigational medicinal product (IMP) formulations
* Participant has participated in another study of an IMP (and/or an investigational device) within the previous 30 days or within 5 times the half-life (whichever is longer) of the first dose of BRV in this study or is currently participating in another study of an IMP (and/or an investigational device)
* Participant tests positive for alcohol and/or prohibited concomitant drugs (including cotinine) at the Screening Visit or on Day-1
* Participant has donated blood or plasma or has experienced blood loss ≥400 mL within 90 days, ≥200 mL within 30 days, or has donated any blood or plasma within 14 days before first administration of IMP
* Participant is a current smoker or has used nicotine-containing products (eg, tobacco, patches, gum) within 30 days before the first administration of IMP

Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes