A SINGLE-CENTER, OPEN-LABEL, RANDOMIZED, SINGLE-DOSE, 3-WAY CROSSOVER STUDY TO EVALUATE THE PHARMACOKINETICS, SAFETY, AND TOLERABILITY OF BRIVARACETAM INTRAVENOUS FORMULATION GIVEN AS A 2-MINUTE IV BOLUS INJECTION, A 15-MINUTE IV INFUSION, AND AN ORALLY-DOSED TABLET IN HEALTHY MALE JAPANESE SUBJECTS

CB Japan Co., Ltd.0 个研究点目标入组 24 人开始时间: 2018年4月10日最近更新: 2023年10月17日

试验速览

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•1)Subject is of normal body weight of 50 to 90kg(inclusive) and body mass index between 18.5 and 26kg/m2.
•2)Subject is willing to abstain from alcohol-, tabacco, and caffeine-containing products for 48 hours prior to admissions to the study site and during the entire in-site stay.
•3)Subjects has blood pressure and pulse rate measurement within normal range, and axillary body temperature between 35.0-37.5 degree.Clinically nonsignificant will be allowed at the discretion of the investigator.
•4)Subject's ECG is considered normal or abnormal but not clinically significant, in the opinion of the investigator.
•5)Result of clinical laboratory tests whithin the reference of the laboratory. Results outside the reference range of the laboratory but considered as not clinically significant by the investigator.

•1)Subjects has a current serious psychiatric disorder requiring or that has required hospitalization or medication within the previous 5 years.
•2)Subjects has a history of chronic alcohol or drug abuse within previous 6 months.
•3)Subjects consumes >40g alcohol/day
•4)Subjects has any concomitant choronic or acute illness.
•5)Subjects is known to have serum hepatitis or is a carrier of HBsAg, HCV, HIV or syphilis.
•6)Subjects has donated blood or blood components or experienced blood loss >400mL within 90days, >200mL within 30 days, or any blood or blood components within 14days of the first IMP administration.

发起方

CB Japan Co., Ltd.