Status:
UNKNOWN
Investigate a Pharmacodynamics Between S-pantoprazole 10, 20, 40mg and Pantoprazole 20, 40mg in Healthy Male Subjects
Lead Sponsor:
Ahn-Gook Pharmaceuticals Co.,Ltd
Conditions:
Healthy Male Subjects
Eligibility:
MALE
20-45 years
Phase:
PHASE1
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT01882296
Last Update
June 20 2013
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