A Study to Compare PK, PD and Safety of CKD-382 in Healthy Subjects

Study Overview
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Brief Summary
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To compare pharmacokinetics, pharmacodynamics and safety after single/multiple administration of CKD-382 and D026 in healthy subjects

Detailed Description
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A randomized, open-label, crossover phase 1 clinical trial to compare pharmacokinetics, pharmacodynamics and safety after single / multiple administration of CKD-382 and D026 in healthy subjects

Official Title
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A Randomized, Open-label, Crossover Phase 1 Clinical Trial to Compare Pharmaciokinetics, Pharmacodynamics and Safetry After Single/ Multiple Administration of CKD-382 and D026 in Healthy Subjects

Conditions
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GERD

Intervention / Treatment
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* Drug: CKD-382(formulation I)
* Drug: CKD-382(formulation II)
* Drug: D026


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Between 19 aged and 50 aged in healthy adult Body weight more than 50kg Body Mass Index more than 18.0 and under 27.0 Who has negative result on Helicobacter Pylori antibody test Exclusion Criteria: Have clinically significant disease that hepatobiliary system, kidney, nervous system, immune system, respiratory system, endocrine system, hemato-oncology disease, cardiovascular system or mental illness, or a history of mental disease. Have a gastrointestinal disease history(including surgery) that can effect drug absorption Hypersensitivity reaction or clinically significant hypersensitivity reaction in the history of Esomeprazole, additives or benzimidazole family.

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: A<br>Period 1: Test drug(CKD-382 formulation I) Period 2: Test drug(CKD-382 formulation II) Period 3: Reference drug(D026) | Drug: CKD-382(formulation I)<br>* 1 tablet administered under fasting condition for 7days<br>Drug: CKD-382(formulation II)<br>* 1 tablet administered under fasting condition for 7days<br>Drug: D026<br>* 1 tablet administered under fasting condition for 7days<br>|
| Experimental: B<br>Period 1: Test drug(CKD-382 formulation II) Period 2: Reference drug(D026) Period 3: Test drug(CKD-382 formulation I) | Drug: CKD-382(formulation I)<br>* 1 tablet administered under fasting condition for 7days<br>Drug: CKD-382(formulation II)<br>* 1 tablet administered under fasting condition for 7days<br>Drug: D026<br>* 1 tablet administered under fasting condition for 7days<br>|
| Experimental: C<br>Period 1: Reference drug(D026) Period 2: Test drug(CKD-382 formulation I) Period 3: Test drug(CKD-382 formulation II) | Drug: CKD-382(formulation I)<br>* 1 tablet administered under fasting condition for 7days<br>Drug: CKD-382(formulation II)<br>* 1 tablet administered under fasting condition for 7days<br>Drug: D026<br>* 1 tablet administered under fasting condition for 7days<br>|
| Experimental: D<br>Period 1: Test drug(CKD-382 formulation I) Period 2: Reference drug(D026) Period 3: Test drug(CKD-382 formulation II) | Drug: CKD-382(formulation I)<br>* 1 tablet administered under fasting condition for 7days<br>Drug: CKD-382(formulation II)<br>* 1 tablet administered under fasting condition for 7days<br>Drug: D026<br>* 1 tablet administered under fasting condition for 7days<br>|
| Experimental: E<br>Period 1: Test drug(CKD-382 formulation II) Period 2: Test drug(CKD-382 formulation I) Period 3: Reference drug(D026) | Drug: CKD-382(formulation I)<br>* 1 tablet administered under fasting condition for 7days<br>Drug: CKD-382(formulation II)<br>* 1 tablet administered under fasting condition for 7days<br>Drug: D026<br>* 1 tablet administered under fasting condition for 7days<br>|
| Experimental: F<br>Period 1: Reference drug(D026) Period 2: Test drug(CKD-382 formulation II) Period 3: Test drug(CKD-382 formulation I) | Drug: CKD-382(formulation I)<br>* 1 tablet administered under fasting condition for 7days<br>Drug: CKD-382(formulation II)<br>* 1 tablet administered under fasting condition for 7days<br>Drug: D026<br>* 1 tablet administered under fasting condition for 7days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUCtau,ss(Area under the plasma drug concentration-time curve within a dosing interval at steady state) Evaluation PK after multiple dose |  | 0 24h | 
| Percent decrease from baseline in integrated gastric acidity for 24-hour interval after 7th dose Evaluation PD for ambulatory 24hr pH monitor |  | Baseline versus Multiple dose during 7 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CKD-382, D026