Clinical trial NCT01775839: Clinical Trial to Evaluate the Influence of Genotype and DDIs of Aspirin on the PK/PD of Clopidogrel and PK of Digoxin
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: DRUG REACTIONS
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2013-01-25
Enrollment: 24
Sex: MALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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

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.

Primary outcomes:
measure: AUC and Cmax of Clopidogrel and Digoxin
timeFrame: pre- and post dose of Clopidogrel, Digoxin administration
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital Clinical Trials Center
Study officials:
affiliation: SNUH
name: In-Jin Jang, MD
role: PRINCIPAL_INVESTIGATOR
References: