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

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

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

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Drug: Aspirin; Drug: Clopidogrel; Drug: Fixed dose combination of clopidogrel/Aspirin

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Pusan, Korea, Republic of
    • Inje University Pusan Paik Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Clopidogrel and Aspirin	Drug: Aspirin; Other Names: Aspirin: Astrix; Drug: Clopidogrel; Clopidogrel and Aspirin separate combination, single dose; Other Names: Clopidogrel: Plavix
Experimental: Copidogrel	Drug: Fixed dose combination of clopidogrel/Aspirin; Fixed dose combination of clopidogrel/aspirin; Other Names: Coprigrel

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Chong Kun Dang Pharmaceutical
• Collaborators: Inje University
• Investigators: Principal Investigator: JH Shon, Ph.D, Inje University

Study record dates

Study Major Dates

• Study Start: December 1, 2010
• Primary Completion (Actual): January 1, 2011
• Study Completion (Actual): September 1, 2011

Study Registration Dates

• First Submitted: December 20, 2010
• First Submitted That Met QC Criteria: August 10, 2012
• First Posted (Estimate): August 13, 2012

Study Record Updates

• Last Update Posted (Estimate): August 13, 2012
• Last Update Submitted That Met QC Criteria: August 10, 2012
• Last Verified: August 1, 2012

More Information

Terms related to this study

• Keywords: Aspirin; Pharmacokinetics; Phase 1; Combination; Clopidogrel
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Fibrinolytic Agents; Fibrin Modulating Agents; Platelet Aggregation Inhibitors; Cyclooxygenase Inhibitors; Antipyretics; Purinergic P2Y Receptor Antagonists; Purinergic P2 Receptor Antagonists; Purinergic Antagonists; Purinergic Agents; Aspirin; Clopidogrel
• Other Study ID Numbers: 119HPS10F