A Study to Compare PK/PD Characteristics and Safety Profiles Between AD-212-A and AD-2121

Study Overview
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Brief Summary
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Primary endpoint of this study is to evaluate the pharmacokinetic and pharmacodynamic characteristics of AD-212-A in healthy subjects.

Detailed Description
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The purpose of this study is to evaluate the pharmacokinetic and pharmacodynamic characteristics and safety profiles of AD-212-A compared with AD-2121 in healthy subjects.

Official Title
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A Randomized, Open-label, 2x2 Crossover-design Clinical Trial to Evaluate the Safety and Pharmacokinetic/Pharmacodynamic Characteristics After Oral Administration of AD-212-A or AD-2121 in Healthy Adult Volunteers

Conditions
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Gastro Esophageal Reflux

Intervention / Treatment
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* Drug: Lansoprazole 15 mg
* Drug: Lansoprazole 15mg/Calcium carbonate 600mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Body weight equal to or greater than 50kg and Body mass index (BMI) between 18.5 kg/m2 and 27.0 kg/m2 at the time of screening visit The Age equal to or greater than 19 in healthy volunteers at the time of screening visit Negative result from Serum Helicobacter pylori antibody at the time of screening visit Exclusion Criteria: Patients with trouble performing Gastric pH monitoring

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-A<br>Period 1 : Reference Drug (AD-2121), Period 2 : Test Drug (AD-212-A) | Drug: Lansoprazole 15 mg<br>* AD-2121 (Lansoprazole 15 mg), Oral, Capsule<br>Drug: Lansoprazole 15mg/Calcium carbonate 600mg<br>* AD-212-A (Lansoprazole 15mg/Calcium carbonate 600mg), Oral, Tablet<br>|
| Experimental: Arm-B<br>Period 1 : Test Drug (AD-212-A), Period 2 : Reference Drug (AD-2121) | Drug: Lansoprazole 15 mg<br>* AD-2121 (Lansoprazole 15 mg), Oral, Capsule<br>Drug: Lansoprazole 15mg/Calcium carbonate 600mg<br>* AD-212-A (Lansoprazole 15mg/Calcium carbonate 600mg), Oral, Tablet<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the plasma concentration-time curve over a dosing interval at steady state (AUCτ,ss) | AUCτ,ss after 7days repeated administration of Lansoprazole | pre-dose to 24 hours of 1st administration versus pre-dose to 24 hours of repeated administration (7days) | 
| Percent Decrease from baseline of Integrated gastric acidity | Percent Decrease from baseline of Integrated gastric acidity after repeated adadministration of Lansoprazole Integrated gastric acidity calculation: (Integrated gastric acidity Before - Integrated gastric acidity after)/Integrated gastric acidity Before*100 Acid concentration (mM) = 1000 ⅹ 10-pH Acidity (mmol.h/L) = (acid in mM at time 't' + acid in mM at time 't-1')/2 ⅹ (t-(t-1)) Integrated Acidity means cumulative sum per second for 24 hours | 24 hours before 1st administration to 24 hours after repeated administration (7days) |