Bioavailability Study of DP-R202 in Healthy Male Volunteers Under Fed Conditions
Phase 1
Completed
- Conditions
- Healthy
- Registration Number
- NCT01421576
- Lead Sponsor
- Alvogen Korea
- Brief Summary
A randomized, open-label, single-dose, crossover clinical trial to evaluate the food effect on the pharmacokinetics of DP-R202 tablet after oral administration in healthy male volunteers.
- Detailed Description
The number of patient is twenty-four.Patients were randomly assigned either DP-R202(Sarpogrelate HCL 300mg, qd) under fasting condition or DP-R202(Sarpogrelate HCL 300mg, qd) after eating foods.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 24
Inclusion Criteria
- 20 to 55 years of healthy volunteers
Exclusion Criteria
- Hypersensitivity Reaction about Sarpogrelate HCL or other antiplatelets
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method Composite of Pharmacokinetics(Cmax, AUClast) 24h
- Secondary Outcome Measures
Name Time Method
Related Research Topics
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Trial Locations
- Locations (1)
Samsung Medical Center
🇰🇷Seoul, Gangnam, Korea, Republic of
Samsung Medical Center🇰🇷Seoul, Gangnam, Korea, Republic of