Pharmacokinetics, Safety and Tolerability of CKD-387 10/500mg BE Phase1

An open-label, randomized, single-dose crossover study to evaluate the pharmacokinetics, safety and tolerability of CKD-387 in helalthy subjects.

Inclusion criteria

• Healthy adult older than 19 years and less than 45 years at the time of screening.
• BMI 18.5~29.9 kg/m2 and body weight more than 50kg.
• Subjects who have consented to the use of appropriate double- pregnancy contraceptive methods up to one months after the last investigational product and not to provide sperm for men.
• Subjects who sign on an informed consent form willingly.

Exclusion criteria

• Subjects who have a clinically significant disease or medical history such as respiratory, hepatic, kidneys, blood, gastrointestinal, endocrine, immune system, skin, nervous and mental disease.
• Subjects who have acute disease within 28 days prior to the first administration.
• Subjects who have history that may affect the ADME.
• Subjects who have medical history or medical abuse history of hypersensitivity from SGLT inhibitors or Biguanides including Metformin or other medications(Aspirin, Antibiotics etc.).
• Subjects who have clinically significant chronic disease.
• Subjects with genetic problems such as galactose intolerance, Lapp lactase deficiency or glucose-galactose mal-absorption.
• Subjects whose laboratory test result are same as below;

• AST,ALT > UNL(Upper Normal Limit)x3
• Fasting glucose level out of 70-125mg/dl
• Creatinine clearance is lower than 80mL/min which is calcuated by Cockcroft-Gault formulation.
• QT>450msec
• Positive urine hCG(female).
• Subjects whoes blood pressure exceeds out of normal range as below at screening.

• SBP : over 100mmHg, under 160mmHg
• DBP : over 60mmHg, under 100mmHg
• Subjects who have been found to be positive in serological tests(HBs antigen, HCV antibody and HIV antibody).
• Subjects who took ETC(Ethical Drug), oriental medicine within 2 weeks prior to the first administration of investigational products.
• Subjects who took OTC(Over-the-counter Drug, including korean galenical drug) within 10 days prior to the first administration of investigational products.
• Subjects who have allergic disease which has clinical significance(But, light allergic rhinitis and ligth allergic dermatitis which do not need medication is exceptional).
• Subjects who can not eat standard meals provided by the institution.
• Subjects who donated whole blood within 60 days, donated the blood components within 20 days prior to the first administration of investigational products.
• Subjects who received blood transfusion within 30 days prior to the first administration of investigational products.
• Subjects who were participated in the other clinical trial within 90 days prior to the first administration of investigational products.
• Subjects who took medication for the induction and inhibition of metabolizing enzymes such as barbiturate drugs within 6months prior to the first administration of investigational products.
• Subjects who have had abnormal diets that can affect the ADME of the drug within 30 days prior to the first administration of investigational products. (Ingestion of grapefruit juice>1L/day or Caffein>5Cups/day).
• Subjects who have took regular alcohol(alcohol>30g/day) prior to the first administration of investigational products.
• Subjects who smoked more than 10 cigarettes per day prior 3months to the first administration of investigational products or cannot discontinue smoking during the clinical trial.
• Subjects who is determined unsuitable to participate in this clinical trial by the investigator.
• Lactating Women.