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To Evaluate the Safety and Pharmacokinetics of "AJU-C715" and "C715R" in Healthy Adults.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence A | Experimental | Period 1: Reference Drug, Single dose/ Period 2: Test Drug, Single dose |
|
| Sequence B | Experimental | Period 1: Test Drug, Single dose/ Period 2: Reference Drug, Single dose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Test Drug | Drug | AJU-C715 |
| |
| Reference Drug |
| Measure | Description | Time Frame |
|---|---|---|
| AUCt of AJU-C715 | Pre-dose(0 hours) ~ 72 hours | |
| Cmax of AJU-C715 | Pre-dose(0 hours) ~ 72 hours |
| Measure | Description | Time Frame |
|---|---|---|
| AUC∞ of AJU-C715 | Pre-dose(0 hours) ~ 72 hours | |
| AUCt/AUC∞ of AJU-C715 | Pre-dose(0 hours) ~ 72 hours | |
| Tmax of AJU-C715 |
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Inclusion Criteria:
Exclusion Criteria:
4. Those who has a history of gastrointestinal disease or surgery which may affect the absorption of the drug.
5. Those who exceeding an alcohol consumption criteria Alcohol: Men - 21 glass/week, Women - 14 glass/week (1 glass: Soju 50 mL, Beer 250mL or liquor: 30mL), Smoke: 20 cigarettes/day.
6. Those who has under
Those who are hypersensitive to component of the Investigational product and have the medical history
Those with active liver disease or persistent elevation of aminotransferase levels of unknown
Those taking cyclosporin
Those with Myopathy
Those with severe Renal Impairment due to Renal Failure
Those who has Genetic problems such as galactose intolerance, Lapp lactose deficiency or glucose-galactose malabsorption 7. Those who has a history of mental illness. 8. Those who are deemed unfit by the investigators to participate in the clinical trial for other reasons.
9. Women who are pregnant or who may be pregnant and breastfeed.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| H+ Yangji Hospital | Seoul | South Korea |
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| ID | Term |
|---|---|
| D050171 | Dyslipidemias |
| ID | Term |
|---|---|
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D004341 | Drug Evaluation |
| ID | Term |
|---|---|
| D000076722 | Drug Development |
| D008919 | Investigative Techniques |
| D005069 | Evaluation Studies as Topic |
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| Drug |
C715R |
|
| Pre-dose(0 hours) ~ 72 hours |
| t1/2 of AJU-C715 | Pre-dose(0 hours) ~ 72 hours |