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Comparative Pharmacokinetics Study of Clopidogrel and Aspirin Fixed-dose Combination Versus Separate Combination-2nd Trial

Information source: Chong Kun Dang Pharmaceutical
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Coronary Artery Disease

Intervention: Clopidogrel and Aspirin (Drug); Fixed dose combination of clopidogrel/aspirin (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Chong Kun Dang Pharmaceutical

Official(s) and/or principal investigator(s):
JL Ghim, Dr., Principal Investigator, Affiliation: Inje University

Summary

The purpose of this study is to compare pharmacokinetics between fixed-dose combination and separate combination of clopidogrel 75mg/aspirin 100mg.

Clinical Details

Official title: Comparative Pharmacokinetics of Clopidogrel 75mg and Aspirin 100mg After Single Oral Administration as a Fixed Dose Combination Versus Separate Combination in Healthy Male Volunteers

Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Assess the pharmacokinetic characteristics of clodiogrel/acetylsalicylic acid.

Secondary outcome: Assess the pharmacokinetic characteristics of salicylic acid.

Eligibility

Minimum age: 20 Years. Maximum age: 55 Years. Gender(s): Male.

Criteria:

Inclusion Criteria:

- A healthy male volunteer aged 20 to 55, and within 20% of ideal body weight.

- Have not any congenital or chronic diseases and medical symptom.

- Appropriate subject for the study judging from examinations(interview, vital signs,

12-lead ECG, physical examination, blood, urinalysis result on screening.

- Able to participate in the entire trial.

- Signed the informed consent form prior to study participation.

Exclusion Criteria:

- Take metabolic enzyme inducing or inhibiting drugs like barbiturates within 28 days

prior to the first IP administration.

- show evidence of acute disease within 28 days prior to the first IP administration.

- Have the medical history of bleeding symptom or bleeding disease

- Have the disease history(ex. Inflammatory intestinal disease, stomach or duodenum

ulcer, liver and bowels disease, appendectomy except of gastrointestinal surgery history) that may influence on the absorption, distribution, metabolism and excretion of the drug.

- Have relevant hypersensitivity against drug or clinically significant allergic

diseases except mild rhinitis that doesn't need medication.

- Have hypersensitivity reaction histories for Clopidogrel or aspirin.

- Have abnormal laboratory result. AST or ALT > 1. 25 times of upper limit/ Total

bilirubin > 1. 5 times of upper limit/ PT, aPTT, BT over upper limit/ Platelet count <150X10^9/L or >350X10^9/L

- A drug abuse or a heavy caffeine consumer (more than 5cups per a day) or a heavy

smoker (more than 10 cigarettes per a day) or a regular alcohol consumer(more than 30g/day) or drinking within 7days prior to the first IP administration.

- Have a diet(Especially, grapefruit juice-within 7days prior to the first IP

administration) that may influence on the absorption, distribution, metabolism and excretion of the drug(s).

- Have donated whole blood within 60 days prior to the first IP administration.

- Participated in the other clinical trials within 90days prior to the first IP

administration.

- Take medicine which affect to this trial within 10 days prior to the first IP

administration.

- Appropriate subject for the trial judging from principal investigator.

Locations and Contacts

Inje University Pusan Paik Hospital, Jin-gu, Pusan, Korea, Republic of
Additional Information

Starting date: August 2011
Last updated: December 20, 2011

Page last updated: August 23, 2015

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