Clinical Study to Evaluate the Pharmacokinetics, Safety and Tolerability of CKD 371 in Healthy Subjects

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

Detailed Description
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To healthy 32 subjects, following treatments are administered dosing in each period and wash-out period is a minimum of 7 days. Reference drug: D745, D759 / Test drug: CKD-371 Pharmacokinetic blood samples are collected up to 48hrs. The pharmacokinetic characteristics and safety are assessed.

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

Conditions
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Type II Diabetes Mellitus

Intervention / Treatment
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* Drug: CKD-371


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy adults volunteers aged between 19 and 45 years old at the time of screening Weight ≥50kg, with calculated body mass index (BMI) of 18.0 to 29.9 kg/m2 at the time of screening 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: 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 Those who have symptoms of acute disease within 28 days of the the first dose of the investigational product Those who with a history of influencing drug absorption, distribution, metabolism, and excretion 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 Those with clinically significant active chronic disease Those with genetic problems such as galactose intolerance, Lapp lactase deficiency or glucose galactose malabsorption 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) Those who test positive for HBs Ag, HCV Ab, HIV Ab, or VDRL Those who have taken prescription medicine (ETCs), including prescription drugs, within 14 days of the first dose Those who have taken over-the-counter medicines (OTC) including herbal medicines within 7 days of the first dose Clinically significant allergic diseases, mild allergic rhinitis that do not require medication, and allergic dermatitis can be selected Those who cannot eat the standard meal provided by the institution Those who donated whole blood within 60 days prior to the first dose or donated component blood within 20 days Those who received a blood transfusion within 30 days prior to the first dose Those who have participated in other clinical studies or bioequivalence studies within 6 months of the first dose and administered the investigational drug 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 Those who have continuously consumed grapefruit juice or caffeine > 5 cups a day, or cannot refrain from intake during hospitalization Consistently drinking alcohol > 30 days or unable to abstain from alcohol during hospitalization Excessive smokers > 20 cigarettes non-daily or unable to quit smoking during hospitalization Pregnant or childbearing potential and lactating women 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 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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sequence 1<br>Period 1 - A single dose of 2 tablets(D745, D759) under fasting condition. Period 2 - A single dose of 1 tablets(CKD-371) under fasting condition. | Drug: CKD-371<br>* PO<br>* Other names: D745, D759;|
| Experimental: Sequence 2<br>Period 1 - A single dose of 1 tablets(CKD-371) under fasting condition. Period 2 - A single dose of 2 tablets(D745, D759) under fasting condition. | Drug: CKD-371<br>* PO<br>* Other names: D745, D759;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUCt of CKD-371, D745+D759 | Area under the CKD-371, D745+D759 concentration in blood-time curve from zero to final | Pre-dose(0hr), post-dose 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48hr | 
| Cmax of CKD-371, D745+D759 | The maximum CKD-388/D418 concentration in blood sampling time | Pre-dose(0hr), post-dose 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48hr |