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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:
ClinicalTrials.gov Identifier:
NCT01388660
First Posted: July 7, 2011
Last Update Posted: March 26, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Doo-Yeoun Cho, Ajou University School of Medicine
July 5, 2011
July 7, 2011
March 26, 2014
June 2011
September 2014   (Final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01388660 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Pharmacokinetic Assessment of Simultaneous Administration of Clopidogrel and Aspirin
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
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.

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).

Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Coronary Artery Disease
  • 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)
  • 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)
  • Experimental: Cloas
    A tablet containing 75 mg of Clopidogrel and 100 mg of Aspirin
    Intervention: Drug: Cloas
  • Active Comparator: Plavix/Astrix
    Simultaneous Administration of Plavix (75 mg of Clopidogrel) and Astrix (100 mg of Aspirin)
    Intervention: Drug: Plavix/Astrix
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
60
December 2014
September 2014   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Male
20 Years to 45 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
 
NCT01388660
BCA006
No
Not Provided
Not Provided
Doo-Yeoun Cho, Ajou University School of Medicine
Ajou University School of Medicine
Not Provided
Principal Investigator: Doo-Yeoun Cho, MD Ajou University School of Medicine
Ajou University School of Medicine
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP