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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

Information source: Seoul National University Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: DRUG REACTIONS

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

Phase: Phase 4

Status: Completed

Sponsored by: Seoul National University Hospital

Official(s) and/or principal investigator(s):
In-Jin Jang, MD, Principal Investigator, Affiliation: SNUH

Summary

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

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Primary outcome: AUC and Cmax of Clopidogrel and Digoxin

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

Minimum age: 20 Years. Maximum age: 45 Years. Gender(s): Male.

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.

Locations and Contacts

Seoul National University Hospital Clinical Trials Center, Seoul 110-744, Korea, Republic of
Additional Information

Starting date: January 2013
Last updated: June 8, 2014

Page last updated: August 23, 2015

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