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To evaluate the safety and pharmacokinetic characteristics of AJU-C711 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-C711 |
| |
| Reference Drug |
| Measure | Description | Time Frame |
|---|---|---|
| AUCt of AJU-C711 | Pre-dose (0 hr) 10, 20, 30, 45 min, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72 hr | |
| Cmax of AJU-C711 | Pre-dose (0 hr) 10, 20, 30, 45 min, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72 hr |
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Inclusion Criteria:
6. Those who agree to contraception during the participation of clinical trial 7. Those who voluntarily decide to participate and agree to comply with the cautions after hearing and fully understanding the detailed description of this clinical trial
Exclusion Criteria:
Those who received investigational product or bioequivalence test drug within 6 months before the first administration of clinical trial drug
Those who take barbiturate and related (causing induction or inhibition of metabolism) drug within 1 month or the first administration of clinical trial drug within 10 days
Those who donated whole blood within 8 weeks, received apheresis within 2 weeks, blood transfusion within 1 month or can't refrain from donating blood from the time of written consent until the end of the study
Those who has a history of gastrointestinal disease or surgery which may affect the absorption of the drug
Those who exceeding an alcohol consumption criteria Alcohol: Men - 21 glass/week, Women - 14 glass/week (1 glass: Soju 50 mL, liquor: 30mL or Beer 250mL)
Those who has under
Those who has a history of mental illness
Those who are deemed unfit by the investigators to participate in the clinical trial for other reasons
Women who are pregnant or who may be pregnant and breastfeed
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bumin Hospital, Seoul, Republic of South Korea | Seoul | South Korea |
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| ID | Term |
|---|---|
| D006937 | Hypercholesterolemia |
| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | 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 |
C711R |
|
| D009750 |
| Nutritional and Metabolic Diseases |