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Clinical Trial to Evaluate the Influence of Genotype on the Pharmacokinetics/Pharmacodynamics of Clopidogrel

Information source: Seoul National University Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Influence of Genotype of Drug Metabolizing Enzyme or Transporter on the Pharmacokinetics/Pharmacodynamics of Clopidogrel; Influence of Aspirin on the Pharmacokinetics/Pharmacodynamics of Clopidogrel

Intervention: Clopidogrel+Aspirin (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Seoul National University Hospital

Official(s) and/or principal investigator(s):
In-Jin Jang, MD, Principal Investigator, Affiliation: Seoul National University Hospital

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

Clinical Details

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

Study design: Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Pharmacokinetics of Clopidogrel

Pharmacodynamics of clopidogrel

Secondary outcome: mRNA/microRNA/endogenous metabolite

Eligibility

Minimum age: 20 Years. Maximum age: 45 Years. Gender(s): Male.

Criteria:

Inclusion Criteria:

- 1. Healthy male subjects aged 20 - 45 years.

- 2. A body weight in the range of 50 kg (inclusive) - 90 kg (exclusive) and a body

mass index (BMI) in the range 18. 5 kg/m2 (inclusive) - 27 kg/m2 (inclusive).

- 3. Sufficient ability to understand the nature of the study and any hazards of

participating in it. Provide written informed consent after being fully. informed about the study procedures. Exclusion Criteria:

- 1. Presence or history of hypersensitivity or allergic reactions to drugs including

investigational product (clopidogrel or aspirin)

- 2. Clinically relevant abnormal medical history that could interfere with the

objectives of the study.

- 3. A subject with history of gastrointestinal disease or surgery (except simple

appendectomy or repair of hernia), which can influence the absorption of the study drug.

- 4. A subject whose lab test results are as follows; Platelet count or PT, aPTT < 0. 9

x lower limit of reference range of > 1. 1 x upper limit of reference range.

- 5. A subject whose SBP is over 160 mmHg or below 90 mmHg and DBP is over 100 mmHg or

below 50 mmHg.

- 6. Presence or history of drug abuse or positive result in urine drug screening test.

- 7. Participation in other clinical trial within 2 months before first dose.

- 8. Use of CYP inducer (ex. rifampin) within 4 weeks before first dose.

- 9. Use of a prescription medicine, herbal medicine within 2 weeks or over-the-counter

medication or vitamin substances within 1 week before first dose.

- 10. Use of grapefruit juice within 1 week before first dose.

- 11. Blood donation during 2 months or apheresis during 1 month before the study.

- 12. Use of alcohol over 21 units/weeks

- 13. Smoking of more than 10 cigarettes/days within 3 months before first dose.

- 14. Subject judged not eligible for study participation by investigator.

Locations and Contacts

Seoul National University Hospital Clinical Trials Center, Seoul 110-744, Korea, Republic of
Additional Information

Starting date: January 2012
Last updated: June 18, 2012

Page last updated: August 23, 2015

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