Pharmacokinetic Assessment of Simultaneous Administration of Clopidogrel and Aspirin

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Ajou University School of Medicine
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
  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
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: 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:


Further study details as provided by Ajou University School of Medicine:

Primary Outcome Measures:
  • Plasma concentration of Clopidogrel, Acetylsalicylic acid, and Salicylic acid [ Time Frame: upto 24 hours after dosing ] [ Designated as safety issue: No ]
    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
Genders 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

No publications provided

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
Health Authority: Korea: Food and Drug Administration

Keywords provided by Ajou University School of Medicine:
Healthy
Platelet Aggregation Inhibitors
Pharmacokinetics

Additional relevant MeSH terms:
Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Heart Diseases
Vascular Diseases
Aspirin
Clopidogrel
Platelet Aggregation Inhibitors
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antipyretics
Antirheumatic Agents
Cardiovascular Agents
Central Nervous System Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Fibrin Modulating Agents
Fibrinolytic Agents
Hematologic Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Purinergic Agents

ClinicalTrials.gov processed this record on October 21, 2014