Status:
COMPLETED
Pharmacokinetics Study for Probucol
Lead Sponsor:
Korea Otsuka Pharmaceutical Co., Ltd.
Conditions:
Healthy
Eligibility:
MALE
20-40 years
Phase:
PHASE4
Brief Summary
To evaluate the safety and pharmacokinetics of probucol by multiple oral administration in healthy male subjects.
Detailed Description
To evaluate the safety and pharmacokinetics of probucol by multiple oral administration of one 250-mg probucol tablet once daily after breakfast (250 mg/day), two 250-mg probucol tablets once daily af...
Eligibility Criteria
Inclusion
- Inclusion criteria
- Korean
- Male
- Age from 20 to 40 years at time of informed consent
- BMI more than 19.0 and less than 25.0
- Subjects who meet the following criteria at the time of the screening
- Subjects with ECG results without AV block and with both of qTc and QRS width within the standard values
- Exclusion criteria
- History or clinical evidence of significant medical history
- Present or previous significant drug allergy to any prescription or OTC medication
Exclusion
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2009
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT01000467
Start Date
February 1 2009
End Date
September 1 2009
Last Update
March 4 2022
Active Locations (1)
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1
Seoul national univeristy
Seoul, South Korea