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

Alvogen

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Dietary Supplement: High fat meal

Study type: Interventional

Funder types: Industry

Identifiers

NCT01421576

DP-SACL-I-002

Details and patient eligibility

About

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.

Full 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.

Enrollment: 24 patients

Sex: Male

Ages: 20 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 20 to 55 years of healthy volunteers

Exclusion criteria

• Hypersensitivity Reaction about Sarpogrelate HCL or other antiplatelets

Trial design

24 participants in 2 patient groups

High fat meal

Active Comparator group

Treatment:

Dietary Supplement: High fat meal

DP-R202

Experimental group

Description:

under fed condition

Treatment:

Dietary Supplement: High fat meal