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

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ClinicalTrials.gov Identifier: NCT01882296
Recruitment Status : Unknown
Verified May 2013 by Ahn-Gook Pharmaceuticals Co.,Ltd.
Recruitment status was:  Not yet recruiting
First Posted : June 20, 2013
Last Update Posted : June 20, 2013
Sponsor:
Information provided by (Responsible Party):
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


Condition or disease Intervention/treatment Phase
Healthy Male Subjects Drug: AGSPT_10 Drug: AGSPT_20 Drug: AGSPT_40 Drug: Pantoprazole_20 Drug: Pantoprazole_40 Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Estimated Primary Completion Date : September 2013

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 24h pH [ Time Frame: 24 hours ]

Secondary Outcome Measures :
  1. %Time pH>6 [ Time Frame: 24 hours ]
    (Time(hour) percent when pH >6) / 24(hours)

  2. % inhibition time gastric pH≤4 [ Time Frame: 24 hours ]
    100-(percent time pH >4)



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
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Responsible Party: Ahn-Gook Pharmaceuticals Co.,Ltd
ClinicalTrials.gov Identifier: NCT01882296    
Other Study ID Numbers: AGSPT_PD
First Posted: June 20, 2013    Key Record Dates
Last Update Posted: June 20, 2013
Last Verified: May 2013
Additional relevant MeSH terms:
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Pantoprazole
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action