Pharmacokinetic Assessment of Simultaneous Administration of Clopidogrel and Aspirin

Study Description

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Brief Summary:

This is a randomized, open-label, single-dose, two-sequence, two-period crossover study to investigate the pharmacokinetics between a tablet containing 75 mg of Clopidogrel and 100 mg of Aspirin and the simultaneous administration of the separate formulations of the two drugs in healthy male volunteers.

Condition or disease	Intervention/treatment	Phase
Coronary Artery Disease	Drug: Cloas; Drug: Plavix/Astrix	Phase 1

Detailed Description:

Eligibility for participation of this study will be determined from demographic information, medical history, physical examination, electrocardiogram (ECG) and clinical laboratory tests within 4 weeks before study drug administration. Subjects suitable for this study will be admitted to the Clinical Trial Center of Ajou Medical Center on the day before dosing, and they will overnight-fasted from 10 p.m. of Day -1.

Subjects will be dosed study drug (a tablet containing 75 mg of Clopidogrel and 100 mg of Aspirin, or the simultaneous administration of the separate formulations of the two drugs) orally with 240 mL of water around 8 a.m. of Day 1. Subjects will be performed scheduled pharmacokinetic sampling upto 24 hours.

After 2 weeks of washout period, Subjects will be dosed study drug by crossover manner, and will be performed scheduled pharmacokinetic sampling upto 24 hours.

Study participation will be ended on post-study visit (Day 25).

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	60 participants
Allocation:	Randomized
Intervention Model:	Crossover Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	A Randomized, Open-label, Single-dose, Two-sequence, Two-period Crossover Study to Investigate The Pharmacokinetics Between a Tablet Containing 75 mg of Clopidogrel and 100 mg of Aspirin and The Simultaneous Administration of The Separate Formulations of The Two Drugs in Healthy Male Volunteers
Study Start Date :	June 2011
Estimated Primary Completion Date :	September 2014
Estimated Study Completion Date :	December 2014

Arms and Interventions

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Arm	Intervention/treatment
Experimental: Cloas; A tablet containing 75 mg of Clopidogrel and 100 mg of Aspirin	Drug: Cloas; A tablet containing 75 mg of Clopidogrel and 100 mg of Aspirin, PO, 2 tablet once daily for Period I & II Day 1 (crossover manner)
Active Comparator: Plavix/Astrix; Simultaneous Administration of Plavix (75 mg of Clopidogrel) and Astrix (100 mg of Aspirin)	Drug: Plavix/Astrix; Simultaneous Administration of Plavix (75 mg of Clopidogrel) and Astrix (100 mg of Aspirin), 2 tablets once daily for Period I & II Day 1 (crossover manner)

Outcome Measures

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Primary Outcome Measures :

1. Plasma concentration of Clopidogrel, Acetylsalicylic acid, and Salicylic acid [ Time Frame: upto 24 hours after dosing ]
   Cmax (maximal plasma concentration) and AUC (area under the time-concentration curve) will be calculated from pharmacokinetic samplings

Eligibility Criteria

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Ages Eligible for Study:	20 Years to 45 Years (Adult)
Sexes Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

• Healthy male subjects aged 20 - 45 years
• With in 20% of ideal body weight, {Ideal body weight=[height(cm)-100]*0.9}
• Agreement with written informed consent

Exclusion Criteria:

• Clinically significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal disease or mental disorder (Past history or present)
• Subject with symptoms of acute disease within 28 days of starting administration of investigational drug
• Subject with known for history which affect on the ADME of drug Clinically significant active chronic disease
• Inadequate result of laboratory test (especially, Platelet count < 150,000, Platelet count > 350,000, AST/ALT > 1.25 x UNL, Total bilirubin > 1.5 x UNL)
• Positive reaction in the HBs Ag, anti-HCV Ab, anti-HIV Ab, VDRL test
• Taking OTC(Over the counter)medicine including oriental medicine within 7 days
• Clinically significant allergic disease (Except for mild allergic rhinitis and dermatitis seems to be not need for medication)
• Subject with known for hypersensitivity reaction to clopidogrel or aspirin analog
• Not able to taking the institutional standard meal
• Previously make whole blood donation within 60 days or component blood donation within 30 days
• Previously participated in other trial within 90 days
• Continued to be taking caffeine (caffeine > 5 cup/day), drinking (alcohol > 30 g/day) and severe heavy smoker (cigarette > 1/2 pack per day)
• An impossible one who participates in clinical trial by investigator's decision including for reason of laboratory test result

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Contacts

Contact: Doo-Yeoun Cho, MD	+82-31-219-4271	dooycho@ajou.ac.kr

Locations

Korea, Republic of
Ajou University School of Medicine	Recruiting
Suwon, Gyeonggi, Korea, Republic of, 433-721
Contact: Doo-Yeoun Cho, MD +82-31-219-4271 dooycho@ajou.ac.kr
Sub-Investigator: Young-Sang Kim, MD

Sponsors and Collaborators

Ajou University School of Medicine

Investigators

Principal Investigator:	Doo-Yeoun Cho, MD	Ajou University School of Medicine

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Doo-Yeoun Cho, Assitant Professor, Ajou University School of Medicine
ClinicalTrials.gov Identifier:	NCT01388660 History of Changes
Other Study ID Numbers:	BCA006
First Posted:	July 7, 2011
Last Update Posted:	March 26, 2014
Last Verified:	March 2014

Keywords provided by Doo-Yeoun Cho, Ajou University School of Medicine:

Healthy; Platelet Aggregation Inhibitors; Pharmacokinetics

Additional relevant MeSH terms:

Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Aspirin; Ticlopidine; Clopidogrel; Platelet Aggregation Inhibitors; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Analgesics

Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Anti-Inflammatory Agents; Antirheumatic Agents; Fibrinolytic Agents; Fibrin Modulating Agents; Molecular Mechanisms of Pharmacological Action; Cyclooxygenase Inhibitors; Enzyme Inhibitors; Antipyretics; Purinergic P2Y Receptor Antagonists; Purinergic P2 Receptor Antagonists; Purinergic Antagonists; Purinergic Agents