Bioavailability Study of DP-R202 in Healthy Male Volunteers Under Fed Conditions

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01421576

Enrollment

Registered

2011-08-23

Start date

2011-07-31

Completion date

2011-07-31

Last updated

2011-08-23

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

Conditions

Healthy

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.

Interventions

DIETARY_SUPPLEMENTHigh fat meal

offer high fat-meal in the morning before drug intake.

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

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
Composite of Pharmacokinetics(Cmax, AUClast)	24h

Countries

South Korea

Outcome results

None listed

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