A Study to Investigate the PK and Safety of CKD-393

Study Overview
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Brief Summary
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A clinical trial to investigate the pharmacokinetics and safety after oral administration of CKD-393

Detailed Description
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A randomized, open-label, single-dose, two-way crossover clinical trial to investigate the pharmacokinetics and safety after oral administration of CKD-393 and co-administration of CKD-501, D759 and H053 under fed condition in healthy adults

Official Title
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A Randomized, Open-label, Single-dose, Two-way Crossover Clinical Trial to Investigate the Pharmacokinetics and Safety After Oral Administration of CKD-393 and Co-administration of CKD-501, D759 and H053 Under Fed Condition in Healthy Adults

Conditions
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Type II Diabetes

Intervention / Treatment
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* Drug: CKD-393 formulation I
* Drug: CKD-393 formulation II
* Drug: D501, D759, H053


Participation Criteria
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Eligibility Criteria
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[Inclusion Criteria] Between 19 aged and 50 aged healthy adult Body weight more than 55kg for male, more than 50kg for female Body Mass Index over 18.5kg/m2 and under 27.0kg/m2 if female, the subject must satisfy more than one of the following: subject who have reached menopause (no natural menstruation for at least 2 years.) subject who is surgically infertile(hysterectomy or bilateral salpingo-oophorectomy, tubal ligation, or in infertile state under other method) [Exclusion Criteria] Subject who is currently with or have diagnosed with clinically significant hepatobiliary(severe hepatopathy, etc.), kidney(severe nephropathy, etc.), neurological, immunologic, respiratory, urinary, gastrointestinal endocrinological(diabetic ketoacidosis, diabetic coma, etc.), hematological, oncological, cardiovascular(heart failure, etc.) or metal illness Subject with one of the following laboratory test results AST, ALT > UNLx1.5 eGRF < 60 ml/min/1.73 m2 (MDRD formula) immuno-serology test results in positive Systolic blood pressure > 150mmHg or <90mmHg, Diastolic blood pressure >100mmHg or <50mmHg Subject who has history of the following and the history may affect safety of the subject or result of this study History of any prescription drug or herbal medicine within 14 days before first administration investigational products History of any non-prescription drug including health food, vitamin within 7 days before first administration investigational products History of drug-metabolizing induction/inhibition enzyme such as barbital

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 55 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: Group 1<br>Period 1: CKD-501, D759, H053 / Period 2: CKD-393 Formulation I / Period 3: CKD-393 Formulation II | Drug: CKD-393 formulation I<br>* single, oral administration of 2 tablets under fed condition<br>Drug: CKD-393 formulation II<br>* single, oral administration of 2 tablets under fed condition<br>Drug: D501, D759, H053<br>* single, oral administration of 1 D501, 1 D759 and 2 H053 under fed condition<br>|
| Experimental: Group 2<br>Period 1: CKD-393 Formulation I / Period 2: CKD-393 Formulation II / Period 3: CKD-501, D759, H053 | Drug: CKD-393 formulation I<br>* single, oral administration of 2 tablets under fed condition<br>Drug: CKD-393 formulation II<br>* single, oral administration of 2 tablets under fed condition<br>Drug: D501, D759, H053<br>* single, oral administration of 1 D501, 1 D759 and 2 H053 under fed condition<br>|
| Experimental: Group 3<br>Period 1: CKD-393 Formulation II / Period 2: CKD-501, D759, H053 / Period 3: CKD-393 Formulation I | Drug: CKD-393 formulation I<br>* single, oral administration of 2 tablets under fed condition<br>Drug: CKD-393 formulation II<br>* single, oral administration of 2 tablets under fed condition<br>Drug: D501, D759, H053<br>* single, oral administration of 1 D501, 1 D759 and 2 H053 under fed condition<br>|
| Experimental: Group 4<br>Period 1: CKD-501, D759, H053 / Period 2: CKD-393 Formulation II / Period 3: CKD-393 Formulation I | Drug: CKD-393 formulation I<br>* single, oral administration of 2 tablets under fed condition<br>Drug: CKD-393 formulation II<br>* single, oral administration of 2 tablets under fed condition<br>Drug: D501, D759, H053<br>* single, oral administration of 1 D501, 1 D759 and 2 H053 under fed condition<br>|
| Experimental: Group 5<br>Period 1: CKD-393 Formulation I / Period 2: CKD-501, D759, H053 / Period 3: CKD-393 Formulation II | Drug: CKD-393 formulation I<br>* single, oral administration of 2 tablets under fed condition<br>Drug: CKD-393 formulation II<br>* single, oral administration of 2 tablets under fed condition<br>Drug: D501, D759, H053<br>* single, oral administration of 1 D501, 1 D759 and 2 H053 under fed condition<br>|
| Experimental: Group 6<br>Period 1: CKD-393 Formulation II / Period 2: CKD-393 Formulation I / Period 3: CKD-501, D759, H053 | Drug: CKD-393 formulation I<br>* single, oral administration of 2 tablets under fed condition<br>Drug: CKD-393 formulation II<br>* single, oral administration of 2 tablets under fed condition<br>Drug: D501, D759, H053<br>* single, oral administration of 1 D501, 1 D759 and 2 H053 under fed condition<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax | Maximum concentration of drug in plasma | 0 h (hours), 0.25 h (hours), 0.5h, 0.75h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 24h, 32h, 48h | 
| AUClast | Area under the plasma drug concentration-time curve to last concentration | 0 h (hours), 0.25 h (hours), 0.5h, 0.75h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 24h, 32h, 48h | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUCinf | Area under the plasma drug concentration-time curve from 0 to infinity | 0 h (hours), 0.25 h (hours), 0.5h, 0.75h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 24h, 32h, 48h | 
| Tmax | Time to maximum plasma concentration | 0 h (hours)h, 0.25 h (hours), 0.5h, 0.75h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 24h, 32h, 48h | 
| t1/2 | Terminal elimination half-life | 0 h (hours), 0.25 h (hours), 0.5h, 0.75h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 24h, 32h, 48h | 
| Vd/F | Apparent Volume of Distribution | 0 h (hours), 0.25 h (hours)h, 0.5h, 0.75h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 24h, 32h, 48h | 
| CL/F | Apparent Clearance | 0 h (hours), 0.25 h (hours), 0.5h, 0.75h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 24h, 32h, 48h | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CKD-393, Type II Diabetes