Back to resultsPharmacokinetic Assessment of Simultaneous Administration of Clopidogrel and Aspirin
Primary Purpose
Coronary Artery Disease
Status
Unknown status
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Cloas
Plavix/Astrix
Sponsored by
About this trial
This is an interventional treatment trial for Coronary Artery Disease focused on measuring Healthy, Platelet Aggregation Inhibitors, Pharmacokinetics
Eligibility 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
Sites / Locations
- Ajou University School of MedicineRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Cloas
Plavix/Astrix
Arm Description
A tablet containing 75 mg of Clopidogrel and 100 mg of Aspirin
Simultaneous Administration of Plavix (75 mg of Clopidogrel) and Astrix (100 mg of Aspirin)
Outcomes
Primary Outcome Measures
Plasma concentration of Clopidogrel, Acetylsalicylic acid, and Salicylic acid
Cmax (maximal plasma concentration) and AUC (area under the time-concentration curve) will be calculated from pharmacokinetic samplings
Secondary Outcome Measures
Full Information
NCT ID
NCT01388660
First Posted
July 5, 2011
Last Updated
March 25, 2014
Sponsor
Ajou University School of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT01388660
Brief Title
Pharmacokinetic Assessment of Simultaneous Administration of Clopidogrel and Aspirin
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 Type
Interventional
2. Study Status
Record Verification Date
March 2014
Overall Recruitment Status
Unknown status
Study Start Date
June 2011 (undefined)
Primary Completion Date
September 2014 (Anticipated)
Study Completion Date
December 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ajou University School of Medicine
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
Healthy, Platelet Aggregation Inhibitors, Pharmacokinetics
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cloas
Arm Type
Experimental
Arm Description
A tablet containing 75 mg of Clopidogrel and 100 mg of Aspirin
Arm Title
Plavix/Astrix
Arm Type
Active Comparator
Arm Description
Simultaneous Administration of Plavix (75 mg of Clopidogrel) and Astrix (100 mg of Aspirin)
Intervention Type
Drug
Intervention Name(s)
Cloas
Intervention Description
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)
Intervention Type
Drug
Intervention Name(s)
Plavix/Astrix
Intervention Description
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)
Primary Outcome Measure Information:
Title
Plasma concentration of Clopidogrel, Acetylsalicylic acid, and Salicylic acid
Description
Cmax (maximal plasma concentration) and AUC (area under the time-concentration curve) will be calculated from pharmacokinetic samplings
Time Frame
upto 24 hours after dosing
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Doo-Yeoun Cho, MD
Phone
+82-31-219-4271
Email
dooycho@ajou.ac.kr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Doo-Yeoun Cho, MD
Organizational Affiliation
Ajou University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ajou University School of Medicine
City
Suwon
State/Province
Gyeonggi
ZIP/Postal Code
433-721
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Doo-Yeoun Cho, MD
Phone
+82-31-219-4271
Email
dooycho@ajou.ac.kr
First Name & Middle Initial & Last Name & Degree
Young-Sang Kim, MD
12. IPD Sharing Statement
Learn more about this trial
Pharmacokinetic Assessment of Simultaneous Administration of Clopidogrel and Aspirin
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