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

Sasamoto Hiroshi0 个研究点目标入组 24 人开始时间: 2022年3月26日最近更新: 2023年10月17日

适应症

试验速览

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•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).

发起方

Sasamoto Hiroshi