Investigate a Pharmacokinetics Between S-pantoprazole 20mg and Pantoprazole 40mg in Healthy Male Subjects

Study Overview
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Brief Summary
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Primary object : Evaluate pharmacokinetic property administered S-pantoprazole 20mg and Pantoprazole 40mg in healthy male subjects Secondary object : Evaluate safety administered S-pantoprazole 20mg and Pantoprazole 40mg in healthy male subjects

Official Title
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A Randomized, Open Label, Single-dose, 2x2 Crossover Study to Investigate a Pharmacokinetics Between S-pantoprazole 20mg and Pantoprazole 40mg in Healthy Male Subjects

Conditions
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Healthy Male Subjects

Intervention / Treatment
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* Drug: AGSPT_L20
* Drug: Pantoloc 40mg


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   26kg/m2 Blood Pressure : 140 > sitting SBP ≥ 90mmHg, 90 > sitting DBP ≥ 60mmHg 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 Hypersensitivity reactions to drugs or 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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AGSPT_L20<br>tablet, q.d. | Drug: AGSPT_L20<br> <br> |
| Active Comparator: Pantoloc 40mg<br>tablet, q.d. | Drug: Pantoloc 40mg<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax |  | 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 24 hours | 
| AUClast |  | 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUCinf |  | 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 24 hours | 
| Tmax |  | 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 24 hours | 
| T1/2β |  | 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 24 hours |