A Phase 1, Open Label, Single-Center, Dose-increasing Study to Determine the Safety and Pharmacokinetics of Single and Repeated oral administration of tolvaptan in Healthy Chinese Volunteers

Fuwai hospital0 个研究点目标入组 72 人开始时间: 2016年2月16日最近更新: 2020年1月13日

适应症

试验速览

暂无简介。

•Body mass index between 19 and 24 kg/m^2, nonsmokers, thorax radiography and electrocardiography without abnormalities, normal values of BP and heart rate and laboratory test results(hematology, blood biochemistry, hepatic function, and urinalysis), negative results on HIV and hepatitis types B and C testing, negative on urine human chorionic gonadotrophin (HCG) test for the female.

•1. weight less than 50kg , body mass index less than 19 or body mass index more than 24
•2.low blood pressure
•3.bradycardia,sinus arrest, sinoatrial block, atrioventricular block, ectopic rhythm Holter monitoring ;
•4.disease or disorders in hepatic, renal, respiratory, immune system and nervous system;
•5.alcohol or drug abuse;
•6.clinical significant allergies to drug or foods;
•7.use of prescription or over-the-counter medication including herbal products within 4 weeks before study initiation;
•8.donate blood or participated in other clinical trials within 3 months before enrollment in the study
•9.positive results on HIV and hepatitis types B and C testing
•10.abnormalities in laboratory test(hematology, blood biochemistry, hepatic function, and urinalysis)
•11. urination disorder

发起方

Fuwai hospital