NCT01421576

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Alvogen Korea · Industry
• Sex: Male
• Age: 20 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	High fat meal	offer high fat-meal in the morning before drug intake.

Timeline

• Start date: 2011-07-01
• Primary completion: 2011-07-01
• Completion: 2011-07-01
• First posted: 2011-08-23
• Last updated: 2011-08-23

Locations

1 site across 1 country: South Korea