Clinical Study to Evaluate the Pharmacokinetics, Safety and Tolerability of CKD-388 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 subjects of fifty-six (56), following treatments are administered dosing in each period and wash-out period is a minimum of 14 days. Reference drug: D418 Tab. / Test drug: CKD-388 Tab. Pharmacokinetic blood samples are collected up to 72hrs. 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-388 in Healthy Subjects

Conditions
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Chronic Hepatitis b

Intervention / Treatment
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* Drug: D418 Tab.
* Drug: CKD-388 Tab.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male volunteers, aged between ≥ 19 and ≤ 45 years old at the time of screening. Weight ≥ 50kg, with calculated body mass index (BMI) of ≥ 18.5 and ≤ 29.9 kg/m2 * BMI = Weight(kg)/ Height(m)2 Individuals who agreed proper contraception during the study and did consent to not donation of sperm 1 month after the last dose of Investigational Product (IP) administration Individuals who voluntary decide to participate and agrees in writing to comply with the precautions after hearing and fully understanding the detailed explanation of this clinical tail Exclusion Criteria: History or presence of clinically significant and sever active cardiovascular, respiratory, hepatobiliary, renal, hematological, gastrointestinal, endocrine, immune, dermatologic, neurologic, or psychiatric disorder. With symptoms indicating acute illness within 28 days prior to the first Investigational Product (IP) administration. Any medical history that may affect drug absorption, distribution, metabolism and excretion. Individuals who had history of hypersensitivity to follow drugs, derivative drugs or others drugs(aspirin and antibiotics etc.) or had history of drug abuse Thiazolidinedione DPP-4 inhibitor Metformin Any clinically significant chronic medical illness. Any genetic disease including galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. Individuals with one of the following laboratory test results in screening AST, ALT > UNL (upper normal limit) x 3 Creatinine clearance ≤ 80 mL/min In ECG result, QTc > 450 msec hCG(+) (only women) Individuals who had positive test results at HBs Ag, anti-HCV Ab, anti-HIV Ab, VDRL. Use of any prescription drugs within 14 days prior to study drug administration. Use of over-the-counter medications and herbal preparations within 7 days prior to study drug administration. History of any clinically significant allergic reaction (However, mild allergic rhinitis or allergic dermatitis which do not required medication may be allowed). Individuals who cannot eat standard meal provided from clinical trial center. Donation of blood within 60 days prior to study drug administration or apheresis within 20 days prior to the first IP administration. Individuals who had received a blood transfusion within 30 days prior to study drug administration. Exposure to any investigational drug within 6 months prior to the first IP administration. Individuals taking any drugs inducing or inhibiting drug metabolizing enzymes including barbiturates within 30 days prior to the first IP administration. Individuals who had consumed grapefruit juice > 5cups/day or caffeine > 5cups/day within 30 days prior to the first IP administration or who cannot stopping consume grapefruit juice or caffeine during clinical study. Individuals who had drinking (alcohol > 30 g/day) within 30 days prior to the first IP administration or who cannot stop drinking. Heavy smoking (more than 10 cigarettes/day) within 30 days prior to screening or who cannot quit smoking during clinical study. Pregnant or women who may be pregnant Subjects having been deemed inappropriate for the trial as determined by the investigator.

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: Reference-Test<br> | Drug: D418 Tab.<br>* 1T<br>* Other names: Reference;Drug: CKD-388 Tab.<br>* 1T<br>* Other names: Test;|
| Experimental: Test-Reference<br> | Drug: D418 Tab.<br>* 1T<br>* Other names: Reference;Drug: CKD-388 Tab.<br>* 1T<br>* Other names: Test;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUCt of CKD-388, D418 | Area under the CKD-388/D418 concentration in blood-time curve from zero to final | Pre-dose (0 hour), post-dose 0.17, 0.33, 0.50, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72 hours | 
| Cmax of CKD-388, D418 | The maximum CKD-388/D418 concentration in blood sampling time t | Pre-dose (0 hour), post-dose 0.17, 0.33, 0.50, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72 hours |