Clinical Trial to Assess the PK/PD of YYD601 20mg After Oral Administration if Healthy Adult Subjects (Phase1)

Study Overview
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Brief Summary
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Clinical Trial to Assess the PK/PD of YYD601 20mg After Oral Administration if Healthy Adult Subjects (Phase1)

Detailed Description
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To evaluate comparatively a characteristics and safety of the PK/PD of single/repeated oral administration YYD601 20mg and Nexium tab 20mg and the effects of food influence the PK/PD of YYD601 20mg in a healthy adults.

Official Title
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A Randomized, Open-label, Cross-over Design Clinical Trial to Assess the Pharmacokinetic/Pharmacodynamic Properties and Safety of YYD601 20mg After Oral Administration in Healthy Adult Subjects (Phase1)

Conditions
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GERD

Intervention / Treatment
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* Drug: YYD601 20mg
* Drug: Nexium tab 20mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy volunteers of over 19 years old at the time of screening. Volunteers weighing over 50 kg with ideal body weight (IBW) between -20%   20% Subjects don't have congenital or chronic disease and is without pathologic symptom or finding on medical exam. Subjects evaluated eligible for the study based on the screening test results such as laboratory tests including serology, hematology, blood chemistry and urinalysis, etc and electrocardiogram(ECG). Subejctys who signed on the written informed consent form and comply with study requirements after listening adn fully understanding the details of this study. Exclusion Criteria: Who has hyper sensitivity reaction about other drugs, ingredients, components of investigator product or compound of benzimidazole. Who has genetic problem like fructose tolerance, glucose-galctose absorption, deficiency or sucrase-iso maltase deficiency. Medical history or evidence (hepatobiliary, renal, cardiovascular, endocrine, respiratory, gastrointestinal, hemato-oncology, central nervous system, psychiatric and musculoskeletal system) that can affect absorption, distribution, metabolism and excretion of a given drug. Subject who has over 141mmHg or under 89mmHg of systolic pressure or over 95mmHg of diastolic pressure in vital sign or over 100 times/min of pulse rate. Who has active liver disease, (AST, ALT, total bilirubin > 2 x LNR), (BUN, creatinine >1.5 x LNR) or clinically abnoramal result at screening test. Creatinine clearance < 80 mL/min (calcaulated by Cockcroft-Gault formula using serum creatinine) History of gastrointestinal disease (e.g., Crohns disease, active peptic ulcer) or gastrointestinal surgery that may affect the absorption of the study drug (excluding simple appendectomy or herniorrhaphy) Treatments for peptic ulcer, esophageal disease, Zollinger-Ellison syndrome diagnosis therapy or clinically related histories within 3 months prior to the first dose. Positive 13C-urea breath test A history of serious trauma within 4 weeks, or resection operation (exculding simiple appendectomy or herniorrhaphy) and/or relevant history or laboratory or clinical findings indicative of acute disease.

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: YYD601 20mg<br>Esomeprazole IR 10mg + esomeprazole SR 10mg | Drug: Nexium tab 20mg<br>* Esomeprazole magnesium trihydrate 22.3mg Effecacy and Effects: GERD and Antibiotics combined therapy to eradicate the Helicobacter pylori<br>* Other names: comparator drug;|
| Active Comparator: Nexium tab 20mg<br>Esomeprazole magnesium trihydrate 22.3mg. Astrazeneca | Drug: YYD601 20mg<br>* Esomeprazole IR 10mg + Esomeprazole SR 10mg (Expected efficacy and effects: GERD)<br>* Other names: Experimental drug;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax | Cmax after single administration and repeated administration | Integrated gastric acidity: Stomach acid test (24pH) on 1 day, 5 day, 11 day, 16 day | 
| AUC | AUC after single administration and repeated administration | Integrated gastric acidity: Stomach acid test (24pH) on 1 day, 5 day, 11 day, 16 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC | AUC after single administration and repeated administration | pH>4(%): stomach acid test(24pH) on -1 day, 5 day, 11 day, 16 day and change in serum gastrin level on -1 day, 1day, 5 day | 
| Tmax | Tmax after single administration and repeated administration | pH>4(%): stomach acid test(24pH) on -1 day, 5 day, 11 day, 16 day and change in serum gastrin level on -1 day, 1day, 5 day | 
| t1/2 | t1/2 after single administration and repeated administration | pH>4(%): stomach acid test(24pH) on -1 day, 5 day, 11 day, 16 day and change in serum gastrin level on -1 day, 1day, 5 day |