A Phase I, Open-Label, Pharmacokinetic Study of tolvaptan in healthy Chinese volunteers

Phase 1

Completed

• Conditions: hyponatremia; Cardiovascular - Other cardiovascular diseases; Metabolic and Endocrine - Other metabolic disorders

• Registration Number: ACTRN12616000207415
• Lead Sponsor: Fuwai hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-02-16
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 72

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pharmacokinetics.<br>Pharmacokinetic parameters (Tmax, Cmax, t1/2, AUC, MRT, Cav, Cmin, Accumulation Index, Fluctuation%,etc)was calculated by the drug concentration data in plasma using non-compartment model (phoenix winnolin software).[For single dose study, blood will be sampled pre-dose, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 48h, 72h, 96h, 144h, 216h, 288h and 432h after administration. <br>For multiple dose study, blood will be sampled <br>1) on day 1, at pre-dose, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 48h adn 72h after first dose;<br>2) pre-dose from day 4 to day 10;<br>3) on Day 10, at 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 48h adn 72h after administration.<br>]