Investigate a Pharmacodynamics Between S-pantoprazole 10, 20, 40mg and Pantoprazole 20, 40mg in Healthy Male Subjects

Study Overview
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Brief Summary
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Primary object: Evaluate Pharmacodynamic property and safety administered S-pantoprazole 10, 20, 40mg and Pantoprazole 20, 40mg in healthy male subjects Secondary object : Evaluate Dose-response of S-pantoprazole and pantoprazole and compare each dose-response

Official Title
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A Block-randomized, Open-Label, Multiple Oral Dosing, Phase I Study to Explore Comparability of the Pharmacodynamics Between S-pantoprazole 10, 20, 40mg and Pantoprazole 20, 40mg in Healthy Male Subjects

Conditions
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Healthy Male Subjects

Intervention / Treatment
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* Drug: AGSPT_10
* Drug: AGSPT_20
* Drug: AGSPT_40
* Drug: Pantoprazole_20
* Drug: Pantoprazole_40


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult healthy males 20 to 45 years at screening BMI : 19kg/m2   26 kg/m2 Blood Pressure : 140 mmHg ≥ sitting SBP ≥ 90 mmHg, 95 mmHg ≥ sitting DBP ≥ 50 mmHg Exclusion Criteria: Have history of significant hepatic, renal gastrointestinal, pulmonary, musculoskeletal, endocrine, neuropsychiatric, hematologic, cardiovascular diseases Have a gastrointestinal disease(ex : Crohn's disease, gastrointestinal ulcer) or surgery (except for Appendectomy, hernia repair) affected the absorption of medications Have history of GERD, Gastric ulcer, Duodenal ulcer and H.pylori positive Hypersensitivity reactions to drugs of clinically significant hypersensitivity reactions in the history of benzimidazole (ex: pantoprazole, NSAID, antibiotic) Have a history of drug abuse unusual diet affected the absorption, distribution, metabolism, excretion of medications Subject who treated with any investigational drugs within 90 days before the administration of investigational drug Subject who takes inhibitors and inducers of drug metabolizing enzyme (Barbiturates etc.) within 30days Previously donate whole blood within 60 days or component blood within 30 days or transfusion within 30 days Subject who have taken habitually caffeine (caffeine > 5 units/day) Subject who have drunken habitually (alcohol > 21 units/week, 1 unit = pure alcohol 10ml)or who are unable to quit drinking during this study or smoker Subjects deemed ineligible by investigator based on other reasons

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Male

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 |
| --- | --- |
| Experimental: AGSPT_10<br>tablet, 10mg, QD, 7days | Drug: AGSPT_10<br>* AGSPT 10mg for 7days administration<br>|
| Experimental: AGSPT_20<br>tablet, 20mg, QD, 7days | Drug: AGSPT_20<br>* AGSPT 20mg for 7days administration<br>|
| Experimental: AGSPT_40<br>tablet, 20mg x 2, QD, 7days | Drug: AGSPT_40<br>* AGSPT 20mg x 2tablet for 7days administration<br>|
| Active Comparator: Pantoprazole_20<br>tablet, 20mg, QD, 7days | Drug: Pantoprazole_20<br>* Pantoprazole 20mg for 7days administration<br>|
| Active Comparator: Pantoprazole_40<br>tablet, 40mg, QD, 7days | Drug: Pantoprazole_40<br>* Pantoprazole 40mg for 7days administration<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 24h pH |  | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| %Time pH>6 | (Time(hour) percent when pH >6) / 24(hours) | 24 hours | 
| % inhibition time gastric pH≤4 | 100-(percent time pH >4) | 24 hours |