Bioequivalence Study of AJU-C715 and C715R in Healthy Adult Volunteers

Inclusion criteria

• Healthy adults aged 19 to less than 60 years at the time of screening
• 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.
• Those who have no congenital chronic disease or chronic disease requiring treatment and who have no pathological symptoms or findings.
• 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.
• 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.
• 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

• 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. 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.

• 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 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.

• Women who are pregnant or who may be pregnant and breastfeed.