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

K

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)

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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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