The Effect of Genetic Polymorphism on Interactions of Clopidogrel and Cilostazol in Healthy Volunteers

Interaction Clinical Trial

Official title:

Randomized, Open-label, Crossover Study to Evaluate the Effect of Genetic Polymorphism on Pharmacokinetic & Pharmacodynamic Interactions of Clopidogrel and Cilostazol in Korean Healthy Adult Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01482117
• Other study ID #: 10-105
• Status: Completed
• Phase: N/A
• First received: November 26, 2011
• Last updated: May 31, 2013
• Start date: November 2011
• Est. completion date: February 2012

Study information

• Verified date: May 2013
• Source: Inje University
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to investigate the effects of genetic polymorphisms on pharmacokinetic and pharmacodynamic interactions of clopidogrel and cilostazol in Korean healthy adult volunteers.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: February 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 45 Years

Eligibility

Inclusion Criteria:

• Healthy male subject whose CYP2C19 genotype was determined

Exclusion Criteria:

• Subject who has abnormal laboratory test results

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Interaction

Intervention

Drug:
• Clopidogrel
single oral administration of 300mg of clopidogrel
• Cilostazol
single oral administration of 100mg cilostazol
• Clopidogrel/Cilostazol
single oral administration of 300mg clopidogrel and 100mg cilostazol

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Inje University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum concentration(Cmax), Area under the concentration(AUC), Inhibition of platelet aggregation(IPA)	9 or 11 point blood sampling according to the interventions	up to 24 hours	Yes