A Phase I, Open-Label, Pharmacokinetic Study of tolvaptan in healthy Chinese volunteers
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 hospital
72 participants
Jul 15, 2011
Interventional
Conditions
Summary
The purpose of this study is to explore the pharmacokinetic property of tolvaptan in Chinese healthy volunteers and provide important information for clinical application.
Eligibility
Inclusion Criteria1
- 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.
Exclusion Criteria11
- weight less than 50kg , body mass index less than 19 or body mass index more than 24
- low blood pressure
- bradycardia,sinus arrest, sinoatrial block, atrioventricular block, ectopic rhythm Holter monitoring ;
- disease or disorders in hepatic, renal, respiratory, immune system and nervous system;
- alcohol or drug abuse;
- clinical significant allergies to drug or foods;
- use of prescription or over-the-counter medication including herbal products within 4 weeks before study initiation;
- donate blood or participated in other clinical trials within 3 months before enrollment in the study
- positive results on HIV and hepatitis types B and C testing
- abnormalities in laboratory test(hematology, blood biochemistry, hepatic function, and urinalysis)
- urination disorder
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Interventions
This clinical trial was conducted at the phase I ward in fuwai hospital All doses supervised at study centre. In single dose study, volunteers were assigned to 4 treatment groups of tolvaptan: 15, 30, 60 and 120mg. After a 10-hour overnight fast, volunteers received a single dose of tolvaptan orally at approximately 8 a.m. on the following morning (day 1) with 200mL water In multiple dose study, volunteers were assigned to 2 treatment groups of tolvaptan: 30 and 60mg..After a 10-hour overnight fast, volunteers received a dose of tolvaptan orally(30 or 60mg) at approximately 8 a.m. on the following morning (day 1) with 200mL water, 3 days after first dose(day 4), volunteers of two groups received oral doses of tolvaptan (same as respective first dose) daily for 6 consecutive days.
Locations(1)
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ACTRN12616000207415