Dyslipidemia, Hypercholesterolemia
Conditions
Brief summary
To Evaluate the Safety and Pharmacokinetic Characteristics of AJU-C716 and C716R in Healthy Adults
Interventions
DRUGTest Drug
AJU-C716
DRUGReference Drug
C716R
Sponsors
AJU Pharm Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
1. Healthy adults between 19 and 55 years of age at the time of screening. 2. Weight ≥ 50 kg for men or ≥ 45 kg for women, with a calculated body mass index(BMI) of 18 to 30 kg/m² at the time of screening. 3. Those who have no congenital chronic disease or chronic disease requiring treatment and who have no pathological symptoms or findings. 4. Those who are eligible for the clinical trial based on laboratory test results(hematology, blood chemistry, serum, and urine tests) and 12-lead ECG findings during screening. 5. 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. 6. Those who agree to use highly effective methods of contraception(excluding hormonal methods) to prevent pregnancy, either for themselves or their spouse/partner, from the first administration of the investigational medicinal product until one week after the last administration, and who agree not to donate sperm or eggs during this period.
Exclusion criteria
1. 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. 2. Those who received investigational product or bioequivalence test drug within 6 months before the first administration of clinical trial drug. 3. 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. 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 * Individuals with severe hepatic impairment, biliary obstruction, or cholestasis * Those taking cyclosporin * Those with myopathy * Those with a history of hypersensitivity or allergy to Sunset Yellow FCF (Yellow No. 5, Sunset Yellow FCF). * 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AUCt of AJU-C716 | Pre-dose(0 hours) ~ 36 hours |
| Cmax of AJU-C716 | Pre-dose(0 hours) ~ 36 hours |
Secondary
| Measure | 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 | 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 |
Countries
South Korea
Outcome results
None listed