A Study to Assess the Bioequivalence Between Brivaracetam Tablet and Dry Syrup in Healthy Male Japanese Study Participants
Condition: Healthy Study Participants
Intervention: brivaracetam; brivaracetam
Intervention description: Study participants will receive a single-dose of brivaractam tablet (reference - Treatment A) administered orally.; Study participants will receive a single-dose of brivaractam dry syrup (test - Treatment B) administered orally.
Intervention MeSH terms: Brivaracetam
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 24.0
Sex: Male
Minimum age: 20 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: brivaracetam; Healthy Study Participants; Phase 1; BRV

Summary:

      The purpose of the study is to demonstrate the bioequivalence between the BRV tablet and BRV
      as dry syrup after a single oral dose in healthy Japanese male study participants.
    

Eligibility criteria:

        Inclusion criteria:

          -  Study participant must be between 20 to 50 years of age (inclusive) at the time of
             signing the Informed Consent Form (ICF)

          -  Study participant is overtly healthy as determined by medical evaluation including
             medical history, physical examination, laboratory tests, and cardiac monitoring

          -  Study participant is of Japanese descent as evidenced by appearance and verbal
             confirmation of familial heritage (a study participant has all 4 Japanese grandparents
             born in Japan)

        Exclusion criteria:

          -  Study participant has used other drugs, including over-the-counter medications,
             herbal/traditional medicines, or dietary supplements (excluding medicines for external
             use),with the exception of paracetamol, within 14 days before first administration of
             IMP or has received a coronavirus disease 2019 (COVID-19) vaccine within 7 days of
             initiating IMP

          -  Study participant has used hepatic enzyme-inducing drugs (eg, glucocorticoids,
             phenobarbital, isoniazid, phenytoin, rifampicin) within 2 months before the first
             administration of Investigational Medicinal Product (IMP)

          -  Study participant has a positive result for hepatitis B surface antigen, hepatitis C
             virus antibody test, human immunodeficiency virus antibody test, or syphilis at
             Screening Visit

          -  Study 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

          -  Study participant is a current smoker or has used nicotine-containing products (eg,
             tobacco, patches, gum) within 30 days before the first administration of IMP

          -  Consumption of more than 600 mg of caffeine/day (1 cup of coffee contains
             approximately 100mg of caffeine, 1 cup of tea approximately 30 mg, and 1 glass of cola
             approximately 20 mg)