ACTRN12613000277741
Completed
Phase 1
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
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Chronic Stable Angina Pectoris
- Sponsor
- Jiangsu Hengrui Medicine Co,. Ltd
- Enrollment
- 36
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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.
Exclusion Criteria
- •1\. weight less than 50kg , weight index less than 19 or weight 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)
Outcomes
Primary Outcomes
Not specified
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