Pharmacokinetic, Pharmacodynamic Profiles and Safety After Oral Administration of Ivabradine in Male Healthy Korean Volunteers

Asan Medical Center

Status and phase: Completed; Phase 1

Conditions: Healthy Individual

Treatments: Drug: Ivabradine and placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01804010

2007-0114

Details and patient eligibility

About

1. To assess the pharmacokinetic profile of ivabradine (S 16257) and its main active metabolite S 18982 in Korean healthy volunteers after oral administration of ivabradine at the doses of 2.5, 5, 10mg and after repeated oral administrations of ivabradine for 4.5 days at the same doses twice daily versus placebo and to use the study results for bridging with Caucasian data.
2. The pharmacodynamic profile of ivabradine versus placebo by measuring its effects on heart rate after single and then after repeated administrations.
3. Clinical safety of ivabradine versus placebo.

Enrollment: 48 patients

Sex: Male

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• age between 18 and 40 years and Korean
• Nonsmoker or smoke less than 5 cigarettes per day
• normal dietary habits
• BMI ranging from 18 to 25 kg/m2
• good physical and mental status, determined by the investigator
• vital signs in resting condition within range: SBP 100-139 mmHg, DBP 50-89 mmHg
• Normal ECG

Exclusion criteria

• Participate any other trial in the last 3 months prior to the study
• History of major psychiatric, medical, surgical disorders
• Acute, or chronic disease
• History of hypersensitivity to at least one drug
• History of alcoholism or positive alcohol breath test
• Positive drug screening results
• known positive serology for HIV1, HIV2, hepatitis B or C
• blood donor within the last 3 month of the study
• regular use of sedatives, hypnotics, tranquillisers

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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48 participants in 2 patient groups, including a placebo group

Ivabradine

Active Comparator group

Description:

Single and repeated oral administrations of 3 doses of ivabradine

Treatment:

Drug: Ivabradine and placebo

Placebo

Placebo Comparator group

Description:

Placebo administration

Treatment:

Drug: Ivabradine and placebo