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Completed

NCT Number: NCT01421576

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

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.

Completed

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Key information

Conditions

Healthy

Age range

20 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Samsung Medical Center

Seoul, Gangnam, 135-710, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 20 to 55 years of healthy volunteers

Exclusion criteria

  • Hypersensitivity Reaction about Sarpogrelate HCL or other antiplatelets

Treatment and study plan

High fat meal

Dietary Supplement

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

Other names: Other Names:, DP-R202 : DP11002-3

Primary outcomes

  1. Composite of Pharmacokinetics(Cmax, AUClast)

    Time frame: 24h

Sponsors and collaborators

Lead sponsor

Alvogen Korea

Industry

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Aug 23, 2011
Registry last updated
Aug 23, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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