Pharmacokinetics and Safety/Tolerability Profile of CKD-379

Study Overview
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Brief Summary
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A study to compare the pharmacokinetics and safety/tolerability between CKD-379 tablet and D759, D745, D150 combination

Detailed Description
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A randomized, open-label, single dose, 3-period, 6-treatment, crossover study to compare the pharmacokinetics and safety/tolerability of CKD-379 in healthy subjects under fed conditions

Official Title
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A Randomized, Open-label, Single Dose, 3-period, 6-treatment, Crossover Study to Compare the Pharmacokinetics and Safety/Tolerability of CKD-379 and Coadministration of D759, D745 and D150 in Healthy Subjects

Conditions
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Type II Diabetes Mellitus

Intervention / Treatment
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* Drug: CKD-379 I
* Drug: CKD-379 II
* Drug: D759+D745+D150


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Between 19 aged and 50 aged in healthy adult 50.0kg ≤ Body weight ≤ 90.0kg and 18.0kg/m2 ≤ body mass index (BMI) ≤ 27.0kg/m2 Exclusion Criteria: Have clinical significant medical history or disease that hepatobiliary system, kidney, nervous system, immune system, respiratory system, digestive system, urinary system, endocrine system(Type I or Type II Diabetes Mellitus, diabetic ketoacidosis ect.), hematological system, cardiovascular system(heart failure, Torsades de pointes etc.), mental illness Have clinical significant medical history or disease that urinary tract infection or genital infection including urosepsis, pyelonephritis Have a gastrointestinal disease(Crohn's disease, ulcer ect.) history that can effect drug absorption or surgery Those who are pregnant or breastfeeding Those who are deemed inappropriate to participate in clinical trial by investigators

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 50 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: Test drug(CKD-379 I) Period 2: Test drug(CKD-379 II) Period 3: Reference drug(D759+D745+D150) | Drug: CKD-379 I<br>* 1 tablet administration under fed condition<br>Drug: CKD-379 II<br>* 1 tablet administration under fed condition<br>Drug: D759+D745+D150<br>* 3 tablet coadministration under fed condition<br>|
| Experimental: Sequence 2<br>Period 1: Test drug(CKD-379 I) Period 2: Reference drug(D759+D745+D150) Period 3: Test drug(CKD-379 II) | Drug: CKD-379 I<br>* 1 tablet administration under fed condition<br>Drug: CKD-379 II<br>* 1 tablet administration under fed condition<br>Drug: D759+D745+D150<br>* 3 tablet coadministration under fed condition<br>|
| Experimental: Sequence 3<br>Period 1: Test drug(CKD-379 II) Period 2: Reference drug(D759+D745+D150) Period 3: Test drug(CKD-379 I) | Drug: CKD-379 I<br>* 1 tablet administration under fed condition<br>Drug: CKD-379 II<br>* 1 tablet administration under fed condition<br>Drug: D759+D745+D150<br>* 3 tablet coadministration under fed condition<br>|
| Experimental: Sequence 4<br>Period 1: Test drug(CKD-379 II) Period 2: Test drug(CKD-379 I) Period 3: Reference drug(D759+D745+D150) | Drug: CKD-379 I<br>* 1 tablet administration under fed condition<br>Drug: CKD-379 II<br>* 1 tablet administration under fed condition<br>Drug: D759+D745+D150<br>* 3 tablet coadministration under fed condition<br>|
| Experimental: Sequence 5<br>Period 1: Reference drug(D759+D745+D150) Period 2: Test drug(CKD-379 I) Period 3: Test drug(CKD-379 II) | Drug: CKD-379 I<br>* 1 tablet administration under fed condition<br>Drug: CKD-379 II<br>* 1 tablet administration under fed condition<br>Drug: D759+D745+D150<br>* 3 tablet coadministration under fed condition<br>|
| Experimental: Sequence 6<br>Period 1: Reference drug(D759+D745+D150) Period 2: Test drug(CKD-379 II) Period 3: Test drug(CKD-379 I) | Drug: CKD-379 I<br>* 1 tablet administration under fed condition<br>Drug: CKD-379 II<br>* 1 tablet administration under fed condition<br>Drug: D759+D745+D150<br>* 3 tablet coadministration under fed condition<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax | Maximum plasma concentration of the drug | 0 48hours | 
| AUClast | Area under the concentration-time curve from the time of dosing to the last measurable concentration | 0 48hours |