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

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Seoul National University

Status and phase

Completed
Phase 4

Conditions

DRUG REACTIONS

Treatments

Drug: Aspirin+Clopidogrel/Digoxin(oral)
Drug: Aspirin+Clopidogrel/Digoxin(IV)

Study type

Interventional

Funder types

Other

Identifiers

NCT01775839
PGX_Clopidogrel_002

Details and patient eligibility

About

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

Full 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

Enrollment

24 patients

Sex

Male

Ages

20 to 45 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

24 participants in 2 patient groups

Aspirin+Clopidogrel/Digoxin(oral)
Experimental group
Description:
Aspirin: Day 1 ~ Day 59(~65; till the EGC) Clopidogrel: Day -3, 26, 54 Digoxin: Day -2, 27, 55
Treatment:
Drug: Aspirin+Clopidogrel/Digoxin(oral)
Aspirin+Clopidogrel/Digoxin(IV)
Experimental group
Description:
Aspirin: Day 1 ~ Day 59(~65; till the EGC) Clopidogrel: Day -3, 26, 54 Digoxin: Day -2, 27, 55
Treatment:
Drug: Aspirin+Clopidogrel/Digoxin(IV)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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