A Single-Dose, Open-Label, Randomized, 2-Way Cross-Over Study to Assess the Bioequivalence between Brivaracetam Tablet and Dry syrup in Healthy Male Japanese Study Participants (A study to assess the bioequivalence between brivaracetam tablet and dry syrup in healthy male Japanese study participants)

UCB Japan Co., Ltd.0 个研究点目标入组 24 人开始时间: 待定最近更新: 2025年4月24日

适应症

试验速览

暂无简介。

•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).

•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 19(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 Investigation Medical 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 >=400mL within 90 days, >=200mL 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 600mg of caffeine/day (1 cup of coffee contains approximately 100mg of caffeine, 1 cup of tea approximately 30mg, and 1 glass of cola approximately 20mg).

Maximum plasma concentration (Cmax)

for a single dose of brivaracetam

Area under the curve from 0 to the time of the last quantifiable concentration (AUC(0-t))

for a single dose of brivaracetam

Percentage of participants with at least one treatment-emergent adverse event (TEAE)
Percentage of participants with at least one treatment-emergent serious adverse event (SAE)

发起方