QT Interval Evaluation Study in Healthy Japanese Adult Male Subjects

Otsuka Pharmaceutical Co., Ltd.0 个研究点开始时间: 2013年12月10日最近更新: 2023年10月17日

适应症

试验速览

暂无简介。

•1) Subjects with hypersensitivity or a history of hypersensitivity to any drug (any prescription or over-the-counter drug)
•2) Subjects who meet any of the following lipid criteria in the fasting state (at time of screening examination)
•LDL cholesterol (LDL-C): 140 mg/dL and over 140 mg/dL
•HDL cholesterol (HDL-C): less than 40 mg/dL
•Triglyceride (TG): 150 mg/dL and over 150 mg/dL
•3) Subjects with convulsive disorder, congenital long QT interval syndrome, or experience of syncope while swimming or history of syncope or loss of consciousness
•4) Subjects with family history of sudden death
•5) Subjects with serum electrolyte abnormality
•6) Subjects with 12-lead ECG findings such as AV block, significant respiratory arrhythmia, frequent extrasystoles, or bundle branch block which may affect electrocardiographic analysis, or those with PR interval, QRS width, or QTcF interval with outside the following standard values
•PR interval: between 100 msec to 220 msec
•QRS width: 140 msec and under 140 msec
•QTcF interval: between 330 msec to 440 msec

发起方