A Study to Compare the Safety, Pharmacokinetics and Pharmacodynamics of YPI 011 to Rabeprazole in Healthy Adult Subjects

Study Overview
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Brief Summary
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A study to compare the safety, pharmacokinetics and pharmacodynamics of YPI 011 to Rabeprazole in healthy adult subjects

Detailed Description
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This study is to compare the safety, pharmacokinetics and pharmacodynamics of YPI 011 to Rabeprazole in healthy adult subjects

Official Title
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A Study to Compare the Safety, Pharmacokinetics and Pharmacodynamics of YPI 011 to Rabeprazole in Healthy Adult Subjects

Conditions
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Gastroesophageal Reflux Disease

Intervention / Treatment
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* Drug: Rabeprazole Sodium 10mg
* Drug: Rabeprazole Sodium 20mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 19 55 years in healthy volunteers BMI is more than 18.0 kg/m^2 , no more than 28.0 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 were judged ineligible by the investigator

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 55 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: YPI-011 10/500mg<br>Part A: 1 tablet administered before the breakfast during 7 days | Drug: Rabeprazole Sodium 10mg<br>* Part A: 1 tablet administered before the breakfast during 7 days<br>* Other names: Reference drug;|
| Experimental: YPI-011 20/500mg<br>Part B: 1 tablet administered before the breakfast during 7 days | Drug: Rabeprazole Sodium 20mg<br>* Part B: 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 |
| --- | --- | --- |
| Integrated gastric acidity | Percent decrease from baseline in integrated gastric acidity for 24 hour interval after 7th dose | From Day 1 up to Day 28 | 
| AUCt,ss | Evaluateion PK Rabeprazole after multiple dose | From Day 1 up to Day 29 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent decrease from baseline in integrated gastric acidity for 24 hour interval after 1 st dose | Evaluateion PD Rabeprazole after multiple dose | 24 hours | 
| Percent of time with gastric pH>4 for 24 hour interval after 1st and 7th dose | Evaluateion PD Rabeprazole after multiple dose | From Day 1 up to Day 28 | 
| Mean and median gastric pH after 1st and 7th dose | Evaluateion PD Rabeprazole after multiple dose | From Day 1 up to Day 28 | 
| AUCτ | Evaluateion PK Rabeprazole after multiple dose | From Day 1 up to Day 29 | 
| Cmax | Evaluateion PK Rabeprazole after multiple dose | From Day 1 up to Day 29 | 
| Tmax | Evaluateion PK Rabeprazole after multiple dose | From Day 1 up to Day 29 | 
| t1/2 | Evaluateion PK Rabeprazole after multiple dose | From Day 1 up to Day 29 | 
| CL/F | Evaluateion PK Rabeprazole after multiple dose | From Day 1 up to Day 29 | 
| Vz/F | Evaluateion PK Rabeprazole after multiple dose | From Day 1 up to Day 29 | 
| Cmin,ss, | Evaluateion PK Rabeprazole after multiple dose | From Day 1 up to Day 29 | 
| Cmax,ss | Evaluateion PK Rabeprazole after multiple dose | From Day 1 up to Day 29 | 
| Cav,ss, | Evaluateion PK Rabeprazole after multiple dose | From Day 1 up to Day 29 | 
| Tmax,ss | Evaluateion PK Rabeprazole after multiple dose | From Day 1 up to Day 29 | 
| t1/2,ss | Evaluateion PK Rabeprazole after multiple dose | From Day 1 up to Day 29 | 
| CLss/F | Evaluateion PK Rabeprazole after multiple dose | From Day 1 up to Day 29 | 
| Vss/F | Evaluateion PK Rabeprazole after multiple dose | From Day 1 up to Day 29 |