Pharmacokinetics and Food Effect of Sarpogrelate HCl CR Formulation in Comparison to Immediate-release Formulation

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Anplag; Drug: UI03SPG300CT

• Registration Number: NCT01841086
• Lead Sponsor: Korea United Pharm. Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-09
• Primary Completion: 2011-11
• Study Completion: 2011-12
• Status Verified: 2013-04
• Study First Submitted: 2013-04-21
• Study First Submitted QC: 2013-04-23
• Last Update Submitted: 2013-04-23
• Study First Posted: 2013-04-26
• Last Update Posted: 2013-04-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 50

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

Arm && Interventions

Group	Intervention	Description
Anplag	Anplag	Sarpogrelate HCl 300mg once a day or 100mg three times a day
Anplag	UI03SPG300CT	Sarpogrelate HCl 300mg once a day or 100mg three times a day
UI03SPG300CT	Anplag	Sarpogrelate HCl 300mg once a day or 100mg three times a day
UI03SPG300CT	UI03SPG300CT	Sarpogrelate HCl 300mg once a day or 100mg three times a day

Primary Outcome Measures

Name	Time	Method
Cmax	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	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 Outcome Measures

Name	Time	Method
tmax, t1/2	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
AUC0-∞	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