A Study to Compare PK, PD and Safety of the AD-213-B and AD-2132

Study Overview
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Brief Summary
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A study to compare safety, pharmacokinetics and pharmacodynamics of AD-213-B to AD-2132 in healthy volunteers.

Official Title
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A Randomized, Open Label, Multi Dose, Cross Over Design Clinical Study to Evaluate the Pharmacokinetic Pharmacodynamic Characteristics and Safety of AD-213-B and AD-2132 After Oral Administration in Healthy Adult Subjects

Conditions
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Gastroesophagus Reflux Disease

Intervention / Treatment
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* Drug: AD-213-B
* Drug: AD-2132


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy adults over 19 years of age. Weight is more than 50kg and BMI is more than 18.0 kg/m^2 , no more than 27.0 kg/m^2. Subject who has been judged to be eligible for clinical laboratory tests and electrocardiogram tests such as serum tests, hematology tests, blood chemistry tests, and urinary tests conducted within four weeks prior to the administration of clinical trials. Subjects who has heard and fully understood the detailed description of this clinical trial and have willingness to sign of informed consent in writing. Exclusion Criteria: A subject who has a history that can affect the absorption, distribution, metabolism, or excretion of a drug. As a result of laboratory tests, the following figures: ALT or AST or total bilirubin > 1.5 times upper limit of normal range. As a result of laboratory tests, the following figures: Creatinine clearance < 80mL/min. Subjects who judged ineligible by the investigator.

Ages Eligible for Study
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Minimum Age: 19 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: ARM 1<br>Period 1 : Reference Drug(AD-2132) Period 2 : Test Drug(AD-213-B) | Drug: AD-213-B<br>* 1 tablet administered before the breakfast during 5 days<br>Drug: AD-2132<br>* 1 tablet administered before the breakfast during 5 days<br>|
| Experimental: ARM 2<br>Period 1 : Test Drug(AD-213-B) Period 2 : Reference Drug(AD-2132) | Drug: AD-213-B<br>* 1 tablet administered before the breakfast during 5 days<br>Drug: AD-2132<br>* 1 tablet administered before the breakfast during 5 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUCtau | Evaluation PK after multiple dose | From Day 1 up to Day 17 | 
| The change of Integrated gastric acidity(%) from baseline | Evaluation PD after multiple dose | 4 times from Day -1 to Day 17 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax | Evaluation PK after single dose | Day 1 | 
| AUClast | Evaluation PK after single dose | Day 1 | 
| AUCinf | Evaluation PK after single dose | Day 1 | 
| Tmax | Evaluation PK after single dose | Day 1 | 
| t1/2 | Evaluation PK after single dose | Day 1 | 
| CL/F | Evaluation PK after single dose | Day 1 | 
| Vd/F | Evaluation PK after single dose | Day 1 | 
| Cmax,ss | Evaluation PK after multiple dose | Day 1 up to Day 17 | 
| Cmin,ss | Evaluation PK after multiple dose | Day 1 up to Day 17 | 
| AUCinf | Evaluation PK after multiple dose | Day 1 up to Day 17 | 
| Tmax,ss | Evaluation PK after multiple dose | Day 1 up to Day 17 | 
| t1/2 | Evaluation PK after multiple dose | Day 1 up to Day 17 | 
| CLss/F | Evaluation PK after multiple dose | Day 1 up to Day 17 | 
| Vdss/F | Evaluation PK after multiple dose | Day 1 up to Day 17 | 
| The change of Integrated gastric acidity(mmol∙hr/L) from baseline | Evaluation PD after multiple dose | 4 times from Day -1 to Day 17 | 
| Percentage of time to maintain gastric pH 4.0 or higher | Evaluation PD after multiple dose | 4 times from Day -1 to Day 17 |