Pharmacokinetics and Safety of DWP14012 Tablet A and Tablet B in Healthy Volunteers

Study Overview
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Brief Summary
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This is a randomized, open-label, single dose study to evaluate the safety and pharmacokinetics of DWP14012 tablet A and DWP14012 tablet B in healthy volunteers

Official Title
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A Randomized, Open-label, Single Dose Study to Evaluate the Safety and Pharmacokinetics of DWP14012 Tablet A and DWP14012 Tablet B in Healthy Volunteers

Conditions
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Healthy

Intervention / Treatment
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* Drug: DWP14012 tablet A
* Drug: DWP14012 tablet B


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy adult aged between 19 and 45 at screening Those whose weight is 55 kg and more and BMI is between 17.5 and 30.5 kg/m2 Subjects who are adequate to be subjects in this study upon judgment of the investigator after physical examination, clinical laboratory test, examination by interview, etc Exclusion Criteria: Subjects who have clinical significant liver, kidney, nervous system, respiratory, endocrine, hematology and oncology, cardiovascular, urinary, and mental diseases or past history Subjects who have gastrointestinal diseases or past history of gastrointestinal diseases (gastrointestinal ulcer, gastritis, gastrospasm, gastroesophageal reflux, Crohn's disease etc.) that may affect safety and pharmacokinetic/pharmacodynamic evaluation of study drug, and those who have past history of gastrointestinal surgery (however, except simple ppendectomy and herniotomy) Subjects who showed positive result for Helicobacter pylori test Subjects with serum AST (SGOT) or ALT (SGPT) level >1.5 times the upper limit of the normal range at the time of the screening examination Subjects with a history of drug abuse or a positive urine screening for drug abuse Subjects who have participated and taken investigational drug in any other clinical trial (including bioequivalence study) within six months prior to study drug administration Subjects who have donated a unit of whole blood within two months or blood components within one month prior to study drug administration

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 45 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: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sequence 1 (Tablet B - Tablet A)<br>Period 1 : DWP14012 tablet B Period 2: DWP14012 tablet A | Drug: DWP14012 tablet A<br>* Period 1: DWP14012 tablet B Period 2: DWP14012 tablet A<br>Drug: DWP14012 tablet B<br>* Period 1: DWP14012 tablet A Period 2: DWP14012 tablet B<br>|
| Experimental: Sequence 2 (Tablet A - Tablet B)<br>Period 1 : DWP14012 tablet A Period 2: DWP14012 tablet B | Drug: DWP14012 tablet A<br>* Period 1: DWP14012 tablet B Period 2: DWP14012 tablet A<br>Drug: DWP14012 tablet B<br>* Period 1: DWP14012 tablet A Period 2: DWP14012 tablet B<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUCt: Area under the drug concentration-time curve from time 0 to tau (dosing interval) | each period | 0 hour (pre-dose), 0.5 hour, 1 hour, 1.5 hour, 2 hour, 2.5 hour, 3 hour, 4 hour, 6 hour, 8 hour, 12 hour, 24 hour, 48 hour | 
| Cmax: Peak concentration of DWP14012 | each period | 0 hour (pre-dose), 0.5 hour, 1 hour, 1.5 hour, 2 hour, 2.5 hour, 3 hour, 4 hour, 6 hour, 8 hour, 12 hour, 24 hour, 48 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUCinf: Area under the drug concentration-time curve from time 0 to infinity | each period | 0 hour (pre-dose), 0.5 hour, 1 hour, 1.5 hour, 2 hour, 2.5 hour, 3 hour, 4 hour, 6 hour, 8 hour, 12 hour, 24 hour, 48 hour | 
| Tmax: Time of maximum concentration | each period | 0 hour (pre-dose), 0.5 hour, 1 hour, 1.5 hour, 2 hour, 2.5 hour, 3 hour, 4 hour, 6 hour, 8 hour, 12 hour, 24 hour, 48 hour | 
| t1/2: Terminal elimination half-life | each period | 0 hour (pre-dose), 0.5 hour, 1 hour, 1.5 hour, 2 hour, 2.5 hour, 3 hour, 4 hour, 6 hour, 8 hour, 12 hour, 24 hour, 48 hour | 
| CL/F: Apperent Clearance | each period | 0 hour (pre-dose), 0.5 hour, 1 hour, 1.5 hour, 2 hour, 2.5 hour, 3 hour, 4 hour, 6 hour, 8 hour, 12 hour, 24 hour, 48 hour | 
| Vd/F: Apparent volume of distribution | each period | 0 hour (pre-dose), 0.5 hour, 1 hour, 1.5 hour, 2 hour, 2.5 hour, 3 hour, 4 hour, 6 hour, 8 hour, 12 hour, 24 hour, 48 hour |