NCT01421576
Completed
Phase 1
A Randomized, Single-dose, 2-sequence, 2-period Crossover Study to Investigate the Food-effect Pharmacokinetics of Sarpogrelate HCl Controlled Release Tablet in Healthy Male Subjects
Alvogen Korea1 site in 1 country24 target enrollmentJuly 2011
ConditionsHealthy
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Healthy
- Sponsor
- Alvogen Korea
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- Composite of Pharmacokinetics(Cmax, AUClast)
- Status
- Completed
- Last Updated
- 14 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •20 to 55 years of healthy volunteers
Exclusion Criteria
- •Hypersensitivity Reaction about Sarpogrelate HCL or other antiplatelets
Outcomes
Primary Outcomes
Composite of Pharmacokinetics(Cmax, AUClast)
Time Frame: 24h
Study Sites (1)
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