Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
To Evaluate the Safety and Pharmacokinetic Characteristics of AJU-C716 and C716R in Healthy Adults
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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-C716 |
| |
| Reference Drug |
| Measure | Description | Time Frame |
|---|---|---|
| AUCt of AJU-C716 | Pre-dose(0 hours) ~ 36 hours | |
| Cmax of AJU-C716 | Pre-dose(0 hours) ~ 36 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Ka of AJU-C716 | Pre-dose(0 hours) ~ 36 hours | |
| Percentage of concentration relative to Cmax of AJU-C716 | Pre-dose(0 hours) ~ 36 hours | |
| AUCinf of AJU-C716 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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 received investigational product or bioequivalence test drug within 6 months before the first administration of clinical trial drug.
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, Beer 250mL or liquor: 30mL), Smoke: 20 cigarettes/day.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| H+ Yangji Hospital, Seoul, Republic of South Korea | Seoul | South Korea |
Not provided
| ID | Term |
|---|---|
| D006937 | Hypercholesterolemia |
| D050171 | Dyslipidemias |
| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D004341 | Drug Evaluation |
| ID | Term |
|---|---|
| D000076722 | Drug Development |
| D008919 | Investigative Techniques |
| D005069 | Evaluation Studies as Topic |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
C716R |
|
| Pre-dose(0 hours) ~ 36 hours |
| AUCt/AUCinf of AJU-C716 | Pre-dose(0 hours) ~ 36 hours |
| t1/2 of AJU-C716 | Pre-dose(0 hours) ~ 36 hours |