A Study to Compare PK, PD and Safety of the AD-206 and Esomeprazole

Study Overview
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Brief Summary
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A study to compare safety, pharmacokinetics and pharmacodynamics of AD-206 to Esomeprazole in healthy male volunteers.

Detailed Description
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This study is to compare the safety, pharmacokinetic characteristics and pharmacodynamic characteristics of AD-206 compared with administration of Esomeprazole in healthy male subjects.

Official Title
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A Randomized, Open-label, Multiple-dose, Crossover Study to Compare the Safety, Pharmacokinetics and Pharmacodynamics of AD-206 to Esomeprazole in Healthy Male Volunteers

Conditions
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Gastritis

Intervention / Treatment
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* Drug: AD-206 20mg
* Drug: Esomeprazole 20mg
* Drug: AD-206 40mg
* Drug: Esomeprazole 40mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 19 50 years in healthy male volunteers BMI is more than 18 kg/m^2 , no more than 27.0 kg/m^2 Subjects who have ability to comprehend the objectives, contents of study and property of study drug before participating in trial and have willingness to sign of informed consent in writing Exclusion Criteria: Presence of medical history or a concurrent disease that may interfere with treatment and safety assessment or completion of this clinical study, including clinically significant disorders in digestive system, neuropsychiatric system, endocrine system, liver, cardiovascular system Subjects who judged ineligible by the investigator

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 A1<br>Period 1: Test Drug(AD-206 20mg) Period 2: Reference Drug(Esomeprazole 20mg) | Drug: AD-206 20mg<br>* 1 tablet administered before the breakfast during 7 days<br>* Other names: Test drug;Drug: Esomeprazole 20mg<br>* 1 tablet administered before the breakfast during 7 days<br>* Other names: Reference Drug;|
| Experimental: Group A2<br>Period 1: Reference Drug(Esomeprazole 20mg) Period 2: Test Drug(AD-206 20mg) | Drug: AD-206 20mg<br>* 1 tablet administered before the breakfast during 7 days<br>* Other names: Test drug;Drug: Esomeprazole 20mg<br>* 1 tablet administered before the breakfast during 7 days<br>* Other names: Reference Drug;|
| Experimental: Group B1<br>Period 1: Test Drug(AD-206 40mg) Period 2: Reference Drug(Esomeprazole 40mg) | Drug: AD-206 40mg<br>* 1 tablet administered before the breakfast during 7 days<br>* Other names: Test drug;Drug: Esomeprazole 40mg<br>* 1 tablet administered before the breakfast during 7 days<br>* Other names: Reference Drug;|
| Experimental: Group B2<br>Period 1: Reference Drug(Esomeprazole 40mg) Period 2: Test Drug(AD-206 40mg) | Drug: AD-206 40mg<br>* 1 tablet administered before the breakfast during 7 days<br>* Other names: Test drug;Drug: Esomeprazole 40mg<br>* 1 tablet administered before the breakfast during 7 days<br>* Other names: Reference Drug;|

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) | Evaluation PK esomeprazole after multiple dose | From Day 1 up to Day 29 | 
| Gastric acidity(After 7days of repeated administration, The change of integrated gastric acidity) | Evaluation PD esomeprazole after multiple dose | Day1 24hrs pH monitoring, Day7 24hrs pH monitoring | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUCtau(Area under the plasma drug concentration-time curve) | Evaluation PK esomeprazole after single dose | Day1 | 
| Cmax(Maximum concentration of drug in plasma) | Evaluation PK esomeprazole after single dose | Day1 | 
| Tmax(Time to maximum plasma concentration) | Evaluation PK esomeprazole after single dose | Day1 | 
| t1/2(Terminal elimination half-life) | Evaluation PK esomeprazole after single dose | Day1 | 
| CL/F(Apparent clearance) | Evaluation PK esomeprazole after single dose | Day1 | 
| Vd/F(Apparent volume of distribution) | Evaluation PK esomeprazole after single dose | Day1 | 
| Cmax,ss(Maximum concentration of drug in plasma at steady state) | Evaluation PK esomeprazole after multiple dose | From Day 1 up to Day 29 | 
| Cmin,ss(Minimum concentration of drug in plasma at steady state) Cmin,SS(Minimum concentration of drug in plasma) | Evaluation PK esomeprazole after multiple dose | From Day 1 up to Day 29 | 
| Cav,ss(Average concentration of drug in plasma at steady state) | Evaluation PK esomeprazole after multiple dose | From Day 1 up to Day 29 | 
| Tmax,ss(Time to maximum plasma concentration at steady state) | Evaluation PK esomeprazole after multiple dose | From Day 1 up to Day 29 | 
| t1/2,ss(Terminal elimination half-life at steady state) | Evaluation PK esomeprazole after multiple dose | From Day 1 up to Day 29 | 
| CLss/F(Apparent Clearance at steady state) | Evaluation PK esomeprazole after multiple dose | From Day 1 up to Day 29 | 
| Vss/F(Apparent Volume of distribution at steady state) | Evaluation PK esomeprazole after multiple dose | From Day 1 up to Day 29 | 
| PTF(Peak trough fluctuation over one dosing interal at steady state) | Evaluation PK esomeprazole after multiple dose | From Day 1 up to Day 29 | 
| After the first administration of esomeprazole, The change of integrated gastric acidity compared to baseline for 24 hours | Evaluation PD esomeprazole | Day1 24hrs pH monitoring | 
| After the first dose and 7 days of repeated dosing, Percentage of time to maintain gastric pH 4.0 or higher for 24 hours | Evaluation PD esomeprazole | Day1 24hrs pH monitoring, Day7 24hrs pH monitoring | 
| After the first administration and 7 days of repeated administration, The median pH measured for 24 hours | Evaluation PD esomeprazole | Day1 24hrs pH monitoring, Day7 24hrs pH monitoring |