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The objective of this study is to compare pharmacokinetics after single oral administration of 2 capsules of YH14659, a fixed-dose combination of clopidogrel and aspirin developed by Yuhan Corporation versus co-administration of Plavix (clopidogrel) and Astrix (aspirin) in healthy male volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental |
| |
| Group B | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| YH14659 | Drug | YH14659 capsule by oral |
| |
| clopidogrel & aspirin |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax and AUCt of clopidogrel | 24hrs | |
| Cmax and AUCt of Acetylsalicylic acid | 24hrs |
| Measure | Description | Time Frame |
|---|---|---|
| Tmax, T1/2, λz and AUC∞ of Clopidogrel and Acetylsalicylic acid - AUCt, Cmax, Tmax, T1/2, λz and AUC∞ of salicylic acid | 24hrs | |
| AUCt, Cmax, Tmax, T1/2, λz and AUC∞ of salicylic acid | 24hrs |
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Inclusion Criteria:
Exclusion Criteria:
Have a known allergy or hypersensitivity to anti-platelet agents
Person with hypotension (SBP ≤ 100mmHg or DBP ≤ 50mmHg) or hypertension (SBP ≥ 150mmHg or DBP ≥ 95mmHg), person whose pulse rate is below 45 or over 100 a minute
Have the following abnormal findings on diagnosis;
Patients with hemorrhage or predisposition to hemorrhage
Have disease or history of stomach or intestinal surgery or resection that would potentially alter absorption of orally administered drugs
Have participated in other clinical studies within 3 months prior to the first administration
Have used any prescription medications including anti-coagulants, anti-platelet agents, thrombolytic drugs and Prostaglandin E1 agents within 2 weeks prior to the first administration or any over-the-counter, non-prescription preparations within 1 week prior to the first administration
Patients with aspirin induced asthma(AIA) or history of AIA
Subject who is judged to be ineligible by principal investigator or sub-investigator
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| Name | Affiliation | Role |
|---|---|---|
| Jang-Hee Hong, M.D., Ph.D. | Chung-Nam National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yuhan Corporation | Seoul | 156-754 | South Korea |
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| ID | Term |
|---|---|
| D054058 | Acute Coronary Syndrome |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D000077144 | Clopidogrel |
| D001241 | Aspirin |
| ID | Term |
|---|---|
| D013988 | Ticlopidine |
| D058924 | Thienopyridines |
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
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| Drug |
clopidogrel tablet(75mg) + aspirin capsules(100mg) by oral |
|
| D009930 |
| Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |