None listed
Conditions
Brief 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.
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
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.
Sponsors
Fuwai hospital
Study design
Allocation
Non-randomised trial
Intervention model
Other
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
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 criteria
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
Outcome results
None listed