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

Phase 4

Completed

• Conditions: DRUG REACTIONS
• Interventions: Drug: Aspirin+Clopidogrel/Digoxin(oral); Drug: Aspirin+Clopidogrel/Digoxin(IV)

• Registration Number: NCT01775839
• Lead Sponsor: Seoul National University Hospital

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

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2013-01-15
• Study First Submitted QC: 2013-01-22
• Study First Posted: 2013-01-25
• Primary Completion: 2014-04
• Study Completion: 2014-04
• Status Verified: 2014-06
• Last Update Submitted: 2014-06-08
• Last Update Posted: 2014-06-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 24

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
AUC and Cmax of Clopidogrel and Digoxin	pre- and post dose of Clopidogrel, Digoxin administration	(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

Trial Locations

Locations (1)

Seoul National University Hospital Clinical Trials Center; 🇰🇷 Seoul, Korea, Republic of