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

Phase 1

• Conditions: Healthy Male Subjects
• Interventions: Drug: AGSPT_10; Drug: AGSPT_20; Drug: AGSPT_40; Drug: Pantoprazole_20; Drug: Pantoprazole_40

• Registration Number: NCT01882296
• Lead Sponsor: Ahn-Gook Pharmaceuticals Co.,Ltd

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-pantoprazole and pantoprazole and compare each dose-response

Detailed Description

Not available

Study Timeline

• Status Verified: 2013-05
• Study First Submitted: 2013-06-18
• Study First Submitted QC: 2013-06-19
• Last Update Submitted: 2013-06-19
• Study First Posted: 2013-06-20
• Last Update Posted: 2013-06-20
• Primary Completion: 2013-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AGSPT_10	AGSPT_10	tablet, 10mg, QD, 7days
AGSPT_20	AGSPT_20	tablet, 20mg, QD, 7days
AGSPT_40	AGSPT_40	tablet, 20mg x 2, QD, 7days
Pantoprazole_20	Pantoprazole_20	tablet, 20mg, QD, 7days
Pantoprazole_40	Pantoprazole_40	tablet, 40mg, QD, 7days

Primary Outcome Measures

Name	Time	Method
24h pH	24 hours

Secondary Outcome Measures

Name	Time	Method
%Time pH>6	24 hours	(Time(hour) percent when pH \>6) / 24(hours)
% inhibition time gastric pH≤4	24 hours	100-(percent time pH \>4)