Clinical Trial to Evaluate the Influence of Genotype and DDIs of Aspirin on the PK/PD of Clopidogrel and PK of Digoxin

NCT ID: NCT01775839

Last Updated: 2014-06-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-31
• Study Completion Date: 2014-04-30

Brief Summary

Clinical trial to evaluate the influence of multiple aspirin administration on PK and PD of co-administered drugs

Detailed Description

Clinical trial to evaluate the influence of genotype of drug metabolizing enzyme or transporter and drug-drug interactions of aspirin co-administration on the pharmacokinetics / pharmacodynamics of clopidogrel and pharmacokinetics of digoxin in healthy volunteers

Conditions

DRUG REACTIONS

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Aspirin+Clopidogrel/Digoxin(oral)

Aspirin: Day 1 \~ Day 59(\~65; till the EGC) Clopidogrel: Day -3, 26, 54 Digoxin: Day -2, 27, 55

Group Type: EXPERIMENTAL

Aspirin+Clopidogrel/Digoxin(oral)

Intervention Type: DRUG

oral administration of digoxin

Aspirin+Clopidogrel/Digoxin(IV)

Aspirin: Day 1 \~ Day 59(\~65; till the EGC) Clopidogrel: Day -3, 26, 54 Digoxin: Day -2, 27, 55

Group Type: EXPERIMENTAL

Aspirin+Clopidogrel/Digoxin(IV)

Intervention Type: DRUG

intravenous administration of digoxin

Interventions

Aspirin+Clopidogrel/Digoxin(oral)

oral administration of digoxin

Intervention Type: DRUG

Aspirin+Clopidogrel/Digoxin(IV)

intravenous administration of digoxin

Intervention Type: DRUG

Other Intervention Names

Aspirin; Clopidogrel; Digoxin; Aspirin; Clopidogrel; Digoxin

Eligibility Criteria

Inclusion Criteria

• Healthy male subjects aged 20 - 45 years.
• 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).
• 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

• Presence or history of hypersensitivity or allergic reactions to drugs including investigational product (clopidogrel, digoxin or aspirin)
• Clinically relevant abnormal medical history that could interfere with the objectives of the study.
• 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.
• 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.
• A subject whose SBP is over 160 mmHg or below 90 mmHg and DBP is over 100 mmHg or below 50 mmHg.
• Clinically significant abnormal findings of ECG during screening test.
• Presence or history of drug abuse or positive result in urine drug screening test.
• Participation in other clinical trial within 2 months before first dose.
• Use of CYP inducer (ex. rifampin) within 4 weeks before first dose.
• Use of a prescription medicine, herbal medicine within 2 weeks or over-the-counter medication or vitamin substances within 1 week before first dose.
• Use of grapefruit juice within 1 week before first dose.
• Blood donation during 2 months or apheresis during 1 month before the study.
• Use of alcohol over 21 units/weeks
• Smoking of more than 10 cigarettes/days within 3 months before first dose.
• Subject judged not eligible for study participation by investigator.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Seoul National University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

In-Jin Jang, MD

Role: PRINCIPAL_INVESTIGATOR

SNUH

Locations

Seoul National University Hospital Clinical Trials Center

Seoul, , South Korea

Countries

South Korea

Other Identifiers

PGX_Clopidogrel_002

Identifier Type: -

Identifier Source: org_study_id