Pharmacokinetics and Food Effect of Sarpogrelate HCl CR Formulation in Comparison to Immediate-release Formulation

Korea United Pharm

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: UI03SPG300CT; Drug: Anplag

Study type: Interventional

Funder types: Industry

Identifiers

NCT01841086

KUP-SPG3-101

Details and patient eligibility

About

The purpose of this study is to evaluate the pharmacokinetics of sarpogrelate controlled-release formulation (CR) in comparison to immediate-release formulation (IR) and Food effect on the pharmacokinetics of sarpogrelate CR.

Enrollment: 50 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

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Anplag

Active Comparator group

Description:

Sarpogrelate HCl 300mg once a day or 100mg three times a day

Treatment:

Drug: Anplag

Drug: UI03SPG300CT

UI03SPG300CT

Experimental group

Description:

Sarpogrelate HCl 300mg once a day or 100mg three times a day

Treatment:

Drug: Anplag

Drug: UI03SPG300CT