A Randomized, Open-label, Single Dose, 3-Treatment, 3-Period Williams-Design to Assess the Pharmacokinetic Characteristics and Food Effect of Sarpogrelate HCl CR Tablets Compared With Sarpogrelate HCl IR Tablets in Healthy Male Subjects
Overview
- Phase
- Phase 1
- Intervention
- Anplag
- Conditions
- Healthy
- Sponsor
- Korea United Pharm. Inc.
- Enrollment
- 50
- Primary Endpoint
- Cmax
- Status
- Completed
- Last Updated
- 13 years ago
Overview
Brief Summary
The purpose of this study is to evaluate the pharmacokinetics of sarpogrelate controlled-release formulation (CR) in comparison to immediate-release formulation (IR) and Food effect on the pharmacokinetics of sarpogrelate CR.
Investigators
Eligibility Criteria
Inclusion Criteria
- •20 to 55 years of healthy volunteers
Exclusion Criteria
- •Hypersensitivity Reaction about Sarpogrelate HCl or other antiplatelets
Arms & Interventions
Anplag
Sarpogrelate HCl 300mg once a day or 100mg three times a day
Intervention: Anplag
Anplag
Sarpogrelate HCl 300mg once a day or 100mg three times a day
Intervention: UI03SPG300CT
UI03SPG300CT
Sarpogrelate HCl 300mg once a day or 100mg three times a day
Intervention: Anplag
UI03SPG300CT
Sarpogrelate HCl 300mg once a day or 100mg three times a day
Intervention: UI03SPG300CT
Outcomes
Primary Outcomes
Cmax
Time Frame: 24h
Active Comparator : predose(0), 0.25, 0.5, 1, 1.5, 2, 3, 6(immediately before 2nd drug intake) , 6.25, 6.5, 7, 7.5, 8, 9, 12(immediately before 3rd drug intake), 12.5, 13, 13.5, 14, 15, 16, 24 hours post-dose Experimental : predose(0), 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24 hours post-dose
AUCt
Time Frame: 24h
Active Comparator : predose(0), 0.25, 0.5, 1, 1.5, 2, 3, 6(immediately before 2nd drug intake) , 6.25, 6.5, 7, 7.5, 8, 9,12(immediately before 3rd drug intake), 12.5, 13, 13.5, 14, 15, 16, 24 hours post-dose Experimental : predose(0), 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24 hours post-dose
Secondary Outcomes
- tmax, t1/2(24h)
- AUC0-∞(24h)