CClinicalTrials.gg
CompletedNCT01775839Updated Jun 10, 2014

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

A Phase 4 interventional study of Aspirin+Clopidogrel/Digoxin(oral) and Aspirin+Clopidogrel/Digoxin(IV) in DRUG REACTIONS, sponsored by Seoul National University Hospital. Completed at 1 site in Korea, Republic of. Open to male participants aged 20 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-06-10.

Sponsored by Seoul National University Hospital · Phase 4, Interventional, and Basic science

Phase
Phase 4
Study type
Interventional
Enrollment
24
Allocation
Randomized
Ages
20 Years to 45 Years
Sex
Male
01

Study summary

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

Read the 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

02

Conditions studied

03

In context

Drug-Related Side Effects and Adverse Reactions

437 studies on the registry are indexed under Drug-Related Side Effects and Adverse Reactions; 76 are open to participants now.

This study's enrollment of 24 is below the median of 103 across 255 interventional studies indexed under Drug-Related Side Effects and Adverse Reactions.

Browse Drug-Related Side Effects and Adverse Reactions studies →

Lead sponsor

Seoul National University Hospital is the lead sponsor of 1,860 studies on the registry; 275 are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 45 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Phase 4
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
24 participants (actual)

Study arms

  • Experimental
    Aspirin+Clopidogrel/Digoxin(oral)

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

    Drug: Aspirin+Clopidogrel/Digoxin(oral)

  • Experimental
    Aspirin+Clopidogrel/Digoxin(IV)

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

    Drug: Aspirin+Clopidogrel/Digoxin(IV)

Interventions

  • DrugAspirin+Clopidogrel/Digoxin(oral)

    oral administration of digoxin

    Also known as: Aspirin, Clopidogrel, Digoxin

  • DrugAspirin+Clopidogrel/Digoxin(IV)

    intravenous administration of digoxin

    Also known as: Aspirin, Clopidogrel, Digoxin

06

What researchers measure

Primary outcomes

  1. AUC and Cmax of Clopidogrel and Digoxin

    (Clopidogrel)Predose and 10, 20, 30, 40, 50 min, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 h postdose on Week 0, 4, 8 (Digoxin) Predose and 10, 20, 30, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 h postdose on Week 0, 4, 8

    Time frame: pre- and post dose of Clopidogrel, Digoxin administration

07

Study locations

1 site
  • Seoul National University Hospital Clinical Trials Center
    Seoul, 110-744, Korea, Republic of
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 10, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01775839
Lead sponsor
Seoul National University Hospital
Responsible party
Sponsor
First posted
Jan 25, 2013
Start date
Jan 2013
Primary completion
Apr 2014
Completion
Apr 2014
Last update
Jun 10, 2014

Study contacts

In-Jin Jang, MD
principal investigator · SNUH

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2014. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion