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

Phase 1

Completed

• Conditions: Chronic Stable Angina Pectoris; Cardiovascular - Coronary heart disease

• Registration Number: ACTRN12613000277741
• Lead Sponsor: Jiangsu Hengrui Medicine Co,. Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-03-07
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: Male
• Target Recruitment: 36

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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
pharmacokinetics[Blood will be sampled pre-dose, and 0.25h, 0.5h, 0.75h, 1h, 1.5h, 2h, 4h, 6h, 8h, 12h, 24h, 48h after dose for single dose and the last repeated dose]