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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12613000277741

Enrollment

Registered

2013-03-07

Start date

2010-07-12

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief 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.

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.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

Male

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.

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)

Outcome results