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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 |
|---|---|---|
| Maximum plasma concentration(Cmax) of clopidogrel | 14 days | |
| Area under the time-concentration curve to last concentration(AUCt) of clopidogrel | 14 days | |
| Maximum plasma concentration(Cmax) of acetylsalicylic acid | 14 days | |
| Area under the time-concentration curve to last concentration(AUCt) of acetylsalicylic acid | 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax of salicylic acid, the major active metabolite of aspirin | 14 days | |
| AUCt of salicylic acid, the major active metabolite of aspirin | 14 days |
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Inclusion Criteria:
Exclusion Criteria:
Received any drug that induce or/and inhibit drug metabolizing enzyme such as barbital within the last 28 days prior to the first administration
Shown symptoms doubtful as an acute disease within the last 28 days prior to the first administration
Have signs of bleeding symptoms or/and history of disease such as: gum bleeding, hard to control hemorrhage, easily suffer from bruise, and etc.
Have disease that can affect absorption, distribution, metabolism and excretion of the drug such as: inflammatory bowel disease, gastric ulcer, duodenal ulcer, hepatic disorders, and gastrointestinal tract surgery except appendectomy
Have a known allergy(except mild allergic rhinitis which does not require treatment) or hypersensitivity to drugs
Have the following abnormal findings on diagnosis;
Have been drug abuse, excessive caffeine (> 5 cups/day), heavy smoking (>10 cigarettes/day), continuous alcohol intake (> 30g/day) or have drunk within the last 7 days prior to the first administration
Have been on a diet that can affect absorption, distribution, metabolism and excretion of the drug (especially grapefruit juice 7 days prior to the first administration)
Donated blood within 60 days prior to the first administration
Participated in any other clinical trials within 60 days prior to the first administration
Have used any drug which is thought to affect this study by principal investigator 10 days prior to the first administration
Subject who is judged to be ineligible by principal investigator or sub-investigator
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| Name | Affiliation | Role |
|---|---|---|
| Jae-Gook Shin, MD, PhD. | Inje University | 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 |