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Trials / Completed

CompletedNCT01841086

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

A Randomized, Open-label, Single Dose, 3-Treatment, 3-Period Williams-Design to Assess the Pharmacokinetic Characteristics and Food Effect of Sarpogrelate HCl CR Tablets Compared With Sarpogrelate HCl IR Tablets in Healthy Male Subjects

Status
Completed
Phase
Phase 1
Study type
Interventional
Enrollment
50 (actual)
Sponsor
Korea United Pharm. Inc. · Industry
Sex
Male
Age
20 Years – 55 Years
Healthy volunteers
Accepted

Summary

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.

Conditions

Interventions

TypeNameDescription
DRUGAnplagSarpogrelate HCl 300mg once a day or 100mg three times a day
DRUGUI03SPG300CTSarpogrelate HCl 300mg once a day or 100mg three times a day

Timeline

Start date
2011-09-01
Primary completion
2011-11-01
Completion
2011-12-01
First posted
2013-04-26
Last updated
2013-04-26

Source: ClinicalTrials.gov record NCT01841086. Inclusion in this directory is not an endorsement.

Pharmacokinetics and Food Effect of Sarpogrelate HCl CR Formulation in Comparison to Immediate-release Formulation (NCT01841086) · Clinical Trials Directory