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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cloas | Experimental | A tablet containing 75 mg of Clopidogrel and 100 mg of Aspirin |
|
| Plavix/Astrix | Active Comparator | Simultaneous Administration of Plavix (75 mg of Clopidogrel) and Astrix (100 mg of Aspirin) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cloas | Drug | 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) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | upto 24 hours after dosing |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Doo-Yeoun Cho, MD | Contact | +82-31-219-4271 | dooycho@ajou.ac.kr |
| Name | Affiliation | Role |
|---|---|---|
| Doo-Yeoun Cho, MD | Ajou University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ajou University School of Medicine | Recruiting | Suwon | Gyeonggi-do | 433-721 | South Korea |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000077144 | Clopidogrel |
| ID | Term |
|---|---|
| D013988 | Ticlopidine |
| D058924 | Thienopyridines |
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
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| Plavix/Astrix | Drug | 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) |
|
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D009930 |
| Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |