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

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

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

Study Overview

• Status: Unknown
• Conditions: Healthy Male Subjects
• Intervention / Treatment: Drug: AGSPT_10; Drug: AGSPT_20; Drug: AGSPT_40; Drug: Pantoprazole_20; Drug: Pantoprazole_40

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AGSPT_10; tablet, 10mg, QD, 7days	Drug: AGSPT_10; AGSPT 10mg for 7days administration
Experimental: AGSPT_20; tablet, 20mg, QD, 7days	Drug: AGSPT_20; AGSPT 20mg for 7days administration
Experimental: AGSPT_40; tablet, 20mg x 2, QD, 7days	Drug: AGSPT_40; AGSPT 20mg x 2tablet for 7days administration
Active Comparator: Pantoprazole_20; tablet, 20mg, QD, 7days	Drug: Pantoprazole_20; Pantoprazole 20mg for 7days administration
Active Comparator: Pantoprazole_40; tablet, 40mg, QD, 7days	Drug: Pantoprazole_40; Pantoprazole 40mg for 7days administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Ahn-Gook Pharmaceuticals Co.,Ltd

Study record dates

Study Major Dates

• Primary Completion (Anticipated): September 1, 2013

Study Registration Dates

• First Submitted: June 18, 2013
• First Submitted That Met QC Criteria: June 19, 2013
• First Posted (Estimate): June 20, 2013

Study Record Updates

• Last Update Posted (Estimate): June 20, 2013
• Last Update Submitted That Met QC Criteria: June 19, 2013
• Last Verified: May 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Gastrointestinal Agents; Anti-Ulcer Agents; Proton Pump Inhibitors; Pantoprazole
• Other Study ID Numbers: AGSPT_PD