Status:

COMPLETED

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

Lead Sponsor:

Alvogen Korea

Conditions:

Healthy

Eligibility:

MALE

20-55 years

Phase:

PHASE1

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.

Eligibility Criteria

Inclusion

  • 20 to 55 years of healthy volunteers

Exclusion

  • Hypersensitivity Reaction about Sarpogrelate HCL or other antiplatelets

Key Trial Info

Start Date :

July 1 2011

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

July 1 2011

Estimated Enrollment :

24 Patients enrolled

Trial Details

Trial ID

NCT01421576

Start Date

July 1 2011

End Date

July 1 2011

Last Update

August 23 2011

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Samsung Medical Center

Seoul, Gangnam, South Korea, 135-710