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
Overview
- Phase
- Phase 1
- Intervention
- Cloas
- Conditions
- Coronary Artery Disease
- Sponsor
- Ajou University School of Medicine
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Plasma concentration of Clopidogrel, Acetylsalicylic acid, and Salicylic acid
- Last Updated
- 12 years ago
Overview
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).
Investigators
Doo-Yeoun Cho
Assitant Professor
Ajou University School of Medicine
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
Arms & Interventions
Cloas
A tablet containing 75 mg of Clopidogrel and 100 mg of Aspirin
Intervention: Cloas
Plavix/Astrix
Simultaneous Administration of Plavix (75 mg of Clopidogrel) and Astrix (100 mg of Aspirin)
Intervention: Plavix/Astrix
Outcomes
Primary Outcomes
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