Evaluate the Pharmacokinetics and Safety of DWP14012 Tablet A and Compare Those of DWP14012 Tablet B in Healthy Subjects

Study Overview
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Brief Summary
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The pharmacokinetics (PK) and safety of oral DWP14012 tablet A will be evaluated and compared with those of DWP14012 tablet B in healthy subjects.

Official Title
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A Randomized, Open-label Study to Evaluate the Pharmacokinetics and Safety of DWP14012 Tablet A and Compare Those of DWP14012 Tablet B in Healthy Subjects

Conditions
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Phase 1 Study, Healthy Volunteers

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 adults >=19years and <=45 years of age BMI >=17.5 kg/m2 and <30.5kg/m2, and body weight >= 55kg for male and >= 45kg for femlae subjects with no abnormal symptoms or findings based on physical examinations subjects determined eligible based on the results of lab tests subjects who agree to participate Exclusion Criteria: Subjects with medical history that can not be participated Subjects with results of lab tests performed at screening which meet any of the following : ALT or AST > 1.5 times the upper limit of normal Diagnosis of Helicobacter pylori (H. pylori) positive result subject who is allergic to IP subject with history of serious alcohol or drug abuse within 1 year prior to screening.

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Part1<br>DWP14012 Tablet A : single/multiple dose, 1 group, 2 period study | Drug: DWP14012 Tablet A<br>* DWP14012 10mg<br>|
| Active Comparator: Part2<br>DWP14012 Tablet A 4T vs DWP14012 Tablet B 1T | Drug: DWP14012 Tablet A<br>* DWP14012 10mg<br>Drug: DWP14012 Tablet B<br>* DWP14012 40mg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| (part 2) AUC last of DWP14012 |  | 0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, and 48 hours after dosing | 
| (part 2) Cmax of DWP14012 |  | 0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, and 48 hours after dosing | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| (Part 2) AUC inf of DWP14012 |  | 0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, and 48 hours after dosing | 
| (Part 2) Tmax of DWP14012 |  | 0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, and 48 hours after dosing | 
| (Part 2) t1/2 of DWP14012 |  | 0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, and 48 hours after dosing | 
| (part 1-period 1) AUC last of DWP14012 |  | 0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, and 48 hours | 
| (part 1-period 1) Cmax of DWP14012 |  | 0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, and 48 hours | 
| (part 1- period 2) AUC last of DWP14012 |  | 0 hours (pre-dose) on Day 5; 12 hours (pre-dose) on Day 7; 0 hours (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 (pre-dose), 12.5, 13, 13.5, 14, 14.5, 15, 16, 18, 20, 24, and 48 hours after dosing on Day 8 | 
| (part 1- period 2) Cmax of DWP14012 |  | 0 hours (pre-dose) on Day 5; 12 hours (pre-dose) on Day 7; 0 hours (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 (pre-dose), 12.5, 13, 13.5, 14, 14.5, 15, 16, 18, 20, 24, and 48 hours after dosing on Day 8 |