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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01775839
First received: January 15, 2013
Last updated: June 8, 2014
Last verified: June 2014

January 15, 2013
June 8, 2014
January 2013
April 2014   (final data collection date for primary outcome measure)
AUC and Cmax of Clopidogrel and Digoxin [ Time Frame: pre- and post dose of Clopidogrel, Digoxin administration ] [ Designated as safety issue: No ]
(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
Same as current
Complete list of historical versions of study NCT01775839 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Clinical Trial to Evaluate the Influence of Genotype and DDIs of Aspirin on the PK/PD of Clopidogrel and PK of Digoxin
Clinical Trial to Evaluate the Influence of Genotype of Drug Metabolizing Enzyme or Transporter and Drug-drug Interactions of Aspirin Co-administration on the PK/PD of Clopidogrel and PK of Digoxin in Healthy Volunteers

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

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

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
DRUG REACTIONS
  • Drug: Aspirin+Clopidogrel/Digoxin(oral)
    oral administration of digoxin
    Other Names:
    • Aspirin
    • Clopidogrel
    • Digoxin
  • Drug: Aspirin+Clopidogrel/Digoxin(IV)
    intravenous administration of digoxin
    Other Names:
    • Aspirin
    • Clopidogrel
    • Digoxin
  • Experimental: Aspirin+Clopidogrel/Digoxin(oral)
    Aspirin: Day 1 ~ Day 59(~65; till the EGC) Clopidogrel: Day -3, 26, 54 Digoxin: Day -2, 27, 55
    Intervention: 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
    Intervention: Drug: Aspirin+Clopidogrel/Digoxin(IV)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
April 2014
April 2014   (final data collection date for primary outcome measure)

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.
Male
20 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01775839
PGX_Clopidogrel_002
Yes
Seoul National University Hospital
Seoul National University Hospital
Not Provided
Principal Investigator: In-Jin Jang, MD SNUH
Seoul National University Hospital
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP