A Study to Compare PK, PD and Safety of the AD-214 10/600mg and Rabeprazole

Study Overview
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Brief Summary
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A study to compare safety, pharmacokinetics and pharmacodynamics of AD-214 10/600mg to Rabeprazole 10mg in healthy volunteers.

Detailed Description
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This study is to compare the safety, pharmacokinetic characteristics and pharmacodynamics characteristics of AD-214 10/600mg compared with administration of Rabeprazole 10mg in healthy volunteers.

Official Title
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A Randomized, Open-label, Multiple-dose, Crossover Study to Compare the Safety, Pharmacokinetics and Pharmacodynamics of AD-214 10/600mg to Rabeprazole 10mg in Healthy Volunteers

Conditions
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Gastroesophageal Reflux Disease

Intervention / Treatment
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* Drug: AD-214 10/600mg
* Drug: Rabeprazole 10mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 19 50 years in healthy volunteers BMI is more than 18.0 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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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: AD-214/Rabeprazole<br>Period 1 : Test Drug(AD-214 10/600mg) Period 2 : Reference Drug(Rabeprazole 10mg) | Drug: AD-214 10/600mg<br>* 1 tablet administered before the breakfast during 7 days<br>* Other names: Test drug;Drug: Rabeprazole 10mg<br>* 1 tablet administered before the breakfast during 7 days<br>* Other names: Reference Drug;|
| Experimental: Rabeprazole/AD-214<br>Period 1 : Reference Drug(Rabeprazole 10mg) Period 2 : Test Drug(AD-214 10/600mg) | Drug: AD-214 10/600mg<br>* 1 tablet administered before the breakfast during 7 days<br>* Other names: Test drug;Drug: Rabeprazole 10mg<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) | Evaluateion PK Rabeprazole 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 Rabeprazole after multiple dose | Day1 24hours pH monitoring, Day7 24hours pH monitoring, Day22 24hours monitoring, Day28 24hours pH monitoring | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUCtau(Area under the plasma drug concentration-time curve) | Evaluation PK Rabeprazole after single dose | Day1 | 
| Cmax(Maximum concentration of drug in plasma) | Evaluation PK Rabeprazole after single dose | Day1 | 
| Tmax(Time to maximum plasma concentration) | Evaluation PK Rabeprazole after single dose | Day1 | 
| t1/2(Terminal elimination half-life) | Evaluation PK Rabeprazole after single dose | Day1 | 
| CL/F(Apparent clearance) | Evaluation PK Rabeprazole after single dose | Day1 | 
| Vd/F(Apparent volume of distribution) | Evaluation PK Rabeprazole after single dose | Day1 | 
| Cmax,ss(Maximum concentration of drug in plasma at steady state) | Evaluation PK Rabeprazole 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 Rabeprazole after multiple dose | From Day 1 up to Day 29 | 
| Cav,ss(Average concentration of drug in plasma at steady state) | Evaluation PK Rabeprazole after multiple dose | From Day 1 up to Day 29 | 
| Tmax,ss(Time to maximum plasma concentration at steady state) | Evaluation PK Rabeprazole after multiple dose | From Day 1 up to Day 29 | 
| t1/2,ss(Terminal elimination half-life at steady state) | Evaluation PK Rabeprazole after multiple dose | From Day 1 up to Day 29 | 
| CLss/F(Apparent Clearance at steady state) | Evaluation PK Rabeprazole after multiple dose | From Day 1 up to Day 29 | 
| Vss/F(Apparent Volume of distribution at steady state) | Evaluation PK Rabeprazole after multiple dose | From Day 1 up to Day 29 | 
| PTF(Peak trough fluctuation over one dosing interal at steady state) | Evaluation PK Rabeprazole 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 Rabeoprazoke | Day1 24hours 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 Rabeoprazoke | Day1 24hours pH monitoring, Day7 24hours pH monitoring, Day22 24hours monitoring, Day28 24hours pH monitoring | 
| After the first administration and 7 days of repeated administration, The median pH measured for 24 hours | Evaluation PD Rabeoprazoke | Day1 24hours pH monitoring, Day7 24hours pH monitoring, Day22 24hours monitoring, Day28 24hours pH monitoring |