Pharmacokinetic Assessment of Simultaneous Administration of Clopidogrel and Aspirin

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.

Verified March 2014 by Doo-Yeoun Cho, Ajou University School of Medicine.
Recruitment status was: Recruiting

Sponsor:

Information provided by (Responsible Party):

Doo-Yeoun Cho, Ajou University School of Medicine

ClinicalTrials.gov Identifier:

NCT01388660

First received: July 5, 2011

Last updated: March 25, 2014

Last verified: March 2014

History of Changes

Purpose

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	Intervention	Phase
Coronary Artery Disease	Drug: Cloas Drug: Plavix/Astrix	Phase 1


Study Type:	Interventional
Study Design:	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

Resource links provided by NLM:

Drug Information available for: Aspirin Clopidogrel bisulfate

U.S. FDA Resources

Further study details as provided by Doo-Yeoun Cho, Ajou University School of Medicine:

Primary Outcome Measures:

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


Estimated Enrollment:	60
Study Start Date:	June 2011
Estimated Study Completion Date:	December 2014
Estimated Primary Completion Date:	September 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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)

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).

Eligibility


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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01388660

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


Responsible Party:	Doo-Yeoun Cho, Assitant Professor, Ajou University School of Medicine
ClinicalTrials.gov Identifier:	NCT01388660 History of Changes
Other Study ID Numbers:	BCA006
Study First Received:	July 5, 2011
Last Updated:	March 25, 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

ClinicalTrials.gov processed this record on August 22, 2017

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