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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01841086

Enrollment

Registered

2013-04-26

Start date

2011-09-30

Completion date

2011-12-31

Last updated

2013-04-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

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.

Interventions

DRUGAnplag

Sarpogrelate HCl 300mg once a day or 100mg three times a day

DRUGUI03SPG300CT

Sarpogrelate HCl 300mg once a day or 100mg three times a day

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

20 Years to 55 Years

Healthy volunteers

Yes

Inclusion criteria

* 20 to 55 years of healthy volunteers

Exclusion criteria

* Hypersensitivity Reaction about Sarpogrelate HCl or other antiplatelets

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026