An Open Label, Randomized, Single Dose Crossover Study to Evaluate the Pharmacokinetics, Safety and Tolerability of CKD 371 in Healthy Subjects

A127_01BE2206

This study is an open-label, randomized, single dose, crossover study to evaluate the pharmacokinetics, safety and tolerability of CKD-388 in healthy subjects

2022-10-21

2022-11-14

2022-11-17

Completed

Early phase I

32

Inclusion Criteria: 1. Healthy adults volunteers aged between 19 and 45 years old at the time of screening 2. Weight ≥50kg, with calculated body mass index (BMI) of 18.0 to 29.9 kg/m2 at the time of screening 3. Individuals who voluntarily decide to participate and agree to comply with the cautions after fully understand the detailed description of this clinical trial Exclusion Criteria: 1. Those with clinically significant diseases or history in cardiovascular system, respiratory system, liver, kidney, hematological, gastrointestinal, endocrine system, immune system, skin system, mental/nervous system, etc 2. Those who have symptoms of acute disease within 28 days of the the first dose of the investigational product 3. Those who with a history of influencing drug absorption, distribution, metabolism, and excretion 4. Those who have a hypersensitivity reaction or a history of clinically significant hypersensitivity reaction or a history of drug abuse inculding SGLT2 inhibitor class component or DPP 4 inhibitor class or same class component drugs containing ingredients 5. Those with clinically significant active chronic disease 6. Those with genetic problems such as galactose intolerance, Lapp lactase deficiency or glucose galactose malabsorption 7. A person who has had one or more of the following results in screening tests including re-examination * AST, ALT \> UNL (upper normal limit) x 2.5 * Fasting glucose \< 70 mg/dL * Calculated by Cockcroft Gault formula Creatinine clearance is 75mL/min or less (Cockcroft Gault GFR = (140 age) \* (Wt in kg) / (72 \* Cr)) * QTc \> 470 msec as a result of ECG * Urine-hCG test is positive(if it is limited to female subjects) 8. Those who test positive for HBs Ag, HCV Ab, HIV Ab, or VDRL 9. Those who have taken prescription medicine (ETCs), including prescription drugs, within 14 days of the first dose 10. Those who have taken over-the-counter medicines (OTC) including herbal medicines within 7 days of the first dose 11. Clinically significant allergic diseases, mild allergic rhinitis that do not require medication, and allergic dermatitis can be selected 12. Those who cannot eat the standard meal provided by the institution 13. Those who donated whole blood within 60 days prior to the first dose or donated component blood within 20 days 14. Those who received a blood transfusion within 30 days prior to the first dose 15. Those who have participated in other clinical studies or bioequivalence studies within 6 months of the first dose and administered the investigational drug 16. Those who had taken any drug known as a strong inducer or inhibitor of drug-metabolizing enzymes within 30 days prior to the first dose of the investigational product 17. Those who have continuously consumed grapefruit juice or caffeine \> 5 cups a day, or cannot refrain from intake during hospitalization 18. Consistently drinking alcohol \> 30 days or unable to abstain from alcohol during hospitalization 19. Excessive smokers \> 20 cigarettes non-daily or unable to quit smoking during hospitalization 20. Pregnant or childbearing potential and lactating women 21. Those who consent to the use of reliable contraception(contraceptive methods other than hormones: use of condoms, intrauterine devices (IUD, IUS), tubal ligation, cervical cap, contraceptive diaphragm, etc.) during the clinical trial and not to donate sperm until 2 month after the last administration of investigational product 22. Clinical laboratory test results and other reasons eg, a person who does not respond to requests and instructions, or who judges the investigator to be inappropriate to participate in the clinical trial with a non-cooperative attitude

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'CROSSOVER', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 32, 'type': 'ACTUAL'}}

2023-03-22