Status:
UNKNOWN
Investigate a Pharmacokinetics Between S-pantoprazole 20mg and Pantoprazole 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 pharmacokinetic property administered S-pantoprazole 20mg and Pantoprazole 40mg in healthy male subjects Secondary object : Evaluate safety administered S-pantoprazole 20mg ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT01821521
Start Date
June 1 2013
Last Update
April 1 2013
Active Locations (1)
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1
Asan Medical Center
Seoul, South Korea