Status:
COMPLETED
Pharmacokinetic, Pharmacodynamic Profiles and Safety After Oral Administration of Ivabradine in Male Healthy Korean Volunteers
Lead Sponsor:
Asan Medical Center
Collaborating Sponsors:
Institut de Recherches Internationales Servier
Conditions:
Healthy Individual
Eligibility:
MALE
18-40 years
Phase:
PHASE1
Brief Summary
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, 10m...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2007
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT01804010
Start Date
May 1 2007
End Date
November 1 2007
Last Update
March 5 2013
Active Locations (1)
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1
Asan Medical Center
Seoul, Seoul, South Korea, 138-736