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

Phase 1

Completed

• Conditions: Coronary Artery Disease
• Interventions: Drug: Fixed dose combination of clopidogrel/Aspirin; Drug: Clopidogrel; Drug: Aspirin

• Registration Number: NCT01663038
• Lead Sponsor: Chong Kun Dang Pharmaceutical

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2010-12
• Study First Submitted: 2010-12-20
• Primary Completion: 2011-01
• Study Completion: 2011-09
• Status Verified: 2012-08
• Study First Submitted QC: 2012-08-10
• Last Update Submitted: 2012-08-10
• Study First Posted: 2012-08-13
• Last Update Posted: 2012-08-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 60

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 does not 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Copidogrel	Fixed dose combination of clopidogrel/Aspirin	-
Clopidogrel and Aspirin	Clopidogrel	-
Clopidogrel and Aspirin	Aspirin	-

Primary Outcome Measures

Name	Time	Method
Cmax of clopidogrel/acetylsalicylic acid	Pre-dose, 0.33h, 0.67h, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 4.5h, 5h, 6h, 8h, 10h, 12h, 24h
AUC of clopidogrel/acetylsalicylic acid	Pre-dose, 0.33h, 0.67h, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 4.5h, 5h, 6h, 8h, 10h, 12h, 24h

Secondary Outcome Measures

Name	Time	Method
Assess Cmax of salicylic acid.	Pre-dose, 0.33h, 0.67h, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 4.5h, 5h, 6h, 8h, 10h, 12h, 24h
Assess AUC of salicylic acid.	Pre-dose, 0.33h, 0.67h, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 4.5h, 5h, 6h, 8h, 10h, 12h, 24h

Trial Locations

Locations (1)

Inje University Pusan Paik Hospital; 🇰🇷 Pusan, Korea, Republic of