A Study to Compare PK and Safety of CKD-381 and D026 in Healthy Male Subjects

Study Overview
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Brief Summary
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A Study to compare pharmacokinetics and safety of CKD-381 and D026 in healthy male subjects

Detailed Description
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A randomized, open-label, multiple-dose, and three-way cross over clinical trial to compare pharmacokinetics and safety of CKD-381 and D026 in healthy male subjects

Official Title
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A Randomized, Open-label, Multiple-dose, and Three-way Crossover Clinical Trial to Compare Pharmacokinetics and Safety of CKD-381 and D026 in Healthy Male Subjects

Conditions
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GERD

Intervention / Treatment
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* Drug: CKD-381(formulation I)
* Drug: CKD-381(formulation II)
* Drug: D026(Nexium 40mg)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Between 19 aged and 50 aged in healthy male adult Body weight more than 55kg Body Mass Index more than 18.5 and under 25 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 that can effect drug absorption or surgery. 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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Male

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 A<br>Period 1: Test drug(CKD-381 formulation I), Period 2: Test drug(CKD-381 formulation II), Period 3: Reference drug(D026) | Drug: CKD-381(formulation I)<br>* 1 tablet administered before the breakfast during 7 days<br>Drug: CKD-381(formulation II)<br>* 1 tablet administered before the breakfast during 7 days<br>Drug: D026(Nexium 40mg)<br>* 1 tablet administered before the breakfast during 7 days<br>|
| Experimental: Group B<br>Period 1: Test drug(CKD-381 formulation II), Period 2: Reference drug(D026), Period 3: Test drug(CKD-381 formulation I) | Drug: CKD-381(formulation I)<br>* 1 tablet administered before the breakfast during 7 days<br>Drug: CKD-381(formulation II)<br>* 1 tablet administered before the breakfast during 7 days<br>Drug: D026(Nexium 40mg)<br>* 1 tablet administered before the breakfast during 7 days<br>|
| Experimental: Group C<br>Period 1: Reference drug(D026), Period 2: Test drug(CKD-381 formulation I), Period 3: Test drug(CKD-381 formulation II) | Drug: CKD-381(formulation I)<br>* 1 tablet administered before the breakfast during 7 days<br>Drug: CKD-381(formulation II)<br>* 1 tablet administered before the breakfast during 7 days<br>Drug: D026(Nexium 40mg)<br>* 1 tablet administered before the breakfast during 7 days<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 esomeprazole after multiple dose | 0 24h | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax,ss(Maximum concentration of drug in plasma at steady state) | Evaluation PK esomeprazole after multiple dose | 0 24h | 
| Tmax,ss(Time to maximum plasma concentration at steady state) | Evaluation PK esomeprazole after multiple dose | 0 24h | 
| t1/2(Terminal elimination half-life) | Evaluation PK esomeprazole after multiple dose | 0 24h | 
| R(Accumulation ratio) | Evaluation PK esomeprazole after multiple dose | 0 24h | 
| CLss/F(Apparent Clearance at steady state) | Evaluation PK esomeprazole after multiple dose | 0 24h | 
| Vss/F(Apparent Volume of distribution at steady state) | Evaluation PK esomeprazole after multiple dose | 0 24h | 
| Cmax(Maximum concentration of drug in plasma) | Evaluation PK esomeprazole after single dose | 0 24h | 
| AUClast(Area under the plasma drug concentration-time curve from 0 to last) | Evaluation PK esomeprazole after single dose | 0 24h | 
| Tmax(Time to maximum plasma concentration) | Evaluation PK esomeprazole after single dose | 0 24h | 
| t1/2(Terminal elimination half-life) | Evaluation PK esomeprazole after single dose | 0 24h | 
| CL/F(Apparent clearance) | Evaluation PK esomeprazole after single dose | 0 24h | 
| Vd/F(Apparent volume of distribution) | Evaluation PK esomeprazole after single dose | 0 24h | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CKD-381, Nexium