To Evaluate the Safety and Pharmacokinetic Characteristics of AJU-C716 and C716R in Healthy Adults

Korábbi kezelés

• 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.

Más betegség

• Those who has a history of gastrointestinal disease or surgery which may affect the absorption of the drug.
• Those who has a history of mental illness.

Laborértékek

• 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

Egyéb

• 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 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.

• Healthy adults between 19 and 55 years of age 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.