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

Alvogen Korea24 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

High fat mealDIETARY_SUPPLEMENT

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

Eligibility

Sex: MALEMin age: 20 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * 20 to 55 years of healthy volunteers Exclusion Criteria: * Hypersensitivity Reaction about Sarpogrelate HCL or other antiplatelets

Locations (1)

Samsung Medical Center

Seoul, Gangnam, South Korea

Outcomes

Primary Outcomes

Composite of Pharmacokinetics(Cmax, AUClast)

Time frame: 24h

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.