Ignite Creation Date:
2025-12-25 @ 12:13 AM
Ignite Modification Date:
2025-12-27 @ 10:17 PM
Study NCT ID:
NCT01503658
Status:
COMPLETED
Last Update Posted:
2012-06-19
First Post:
2012-01-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Trial to Evaluate the Influence of Genotype on the Pharmacokinetics/Pharmacodynamics of Clopidogrel
Sponsor:
Seoul National University Hospital
Organization:
Study Overview
Official Title:
Clinical Trial to Evaluate the Influence of Genotype of Drug Metabolizing Enzyme or Transporter and Drug-drug Interactions on the Pharmacokinetics/Pharmacodynamics of Clopidogrel in Healthy Volunteers
Status:
COMPLETED
Status Verified Date:
2012-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study has an open-label, five-period, single-sequence design. The purpose of this study is as follows;
1. Primary
* To evaluate the influence of genotype of drug metabolizing enzyme or transporter on the pharmacokinetics/pharmacodynamics of clopidogrel
* To evaluate the influence of aspirin on the pharmacokinetics/pharmacodynamics of clopidogrel
2. Secondary
* To explore the representative biomarkers for the variable pharmacokinetics/pharmacodynamics of clopidogrel
* To evaluate the influence of genotype of drug metabolizing enzyme or transporter on the drug-drug interactions between aspirin and clopidogrel
* To explore the representative biomarkers for the drug-drug interactions between aspirin and clopidogrel
1. Primary
* To evaluate the influence of genotype of drug metabolizing enzyme or transporter on the pharmacokinetics/pharmacodynamics of clopidogrel
* To evaluate the influence of aspirin on the pharmacokinetics/pharmacodynamics of clopidogrel
2. Secondary
* To explore the representative biomarkers for the variable pharmacokinetics/pharmacodynamics of clopidogrel
* To evaluate the influence of genotype of drug metabolizing enzyme or transporter on the drug-drug interactions between aspirin and clopidogrel
* To explore the representative biomarkers for the drug-drug interactions between aspirin and clopidogrel
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: