A Phase I, Open-Label, Pharmacokinetic Study of ivabradine 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 ivabradine in Healthy Chinese Volunteers
Jiangsu Hengrui Medicine Co,. Ltd
36 participants
Jul 12, 2010
Interventional
Conditions
Summary
The purpose of this study is to explore the pharmacokinetic property as well as the safety and tolerance of ivabradine in Chinese healthy volunteers and provide important information for phase II study.
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.
Exclusion Criteria10
- weight less than 50kg , weight index less than 19 or weight 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)
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Interventions
All volunteers were randomly assigned, using a computer generated table of random numbers, to 3 treatment groups of ivabradine: 5, 10, 20mg. After a 10-hour overnight fast, volunteers received a single dose of ivabradine orally at approximately 8 a.m. on the following morning (day 1) with 200mL water. 3 days after single dose, volunteers of all three group received repeated oral doses of ivabradine (same as respective single dose) twice daily at 8 a.m and 8 p.m. for 6 consecutive days.
Locations(1)
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ACTRN12613000277741