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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT01882296
Other study ID # AGSPT_PD
Secondary ID
Status Not yet recruiting
Phase Phase 1
First received June 18, 2013
Last updated June 19, 2013

Study information

Verified date May 2013
Source Ahn-Gook Pharmaceuticals Co.,Ltd
Contact n/a
Is FDA regulated No
Health authority Korea: Ministry of Food and Drug Safety
Study type Interventional

Clinical Trial 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


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 40
Est. completion date
Est. primary completion date September 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 20 Years to 45 Years
Eligibility 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

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
AGSPT_10
AGSPT 10mg for 7days administration
AGSPT_20
AGSPT 20mg for 7days administration
AGSPT_40
AGSPT 20mg x 2tablet for 7days administration
Pantoprazole_20
Pantoprazole 20mg for 7days administration
Pantoprazole_40
Pantoprazole 40mg for 7days administration

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Ahn-Gook Pharmaceuticals Co.,Ltd

Outcome

Type Measure Description Time frame Safety issue
Primary 24h pH 24 hours No
Secondary %Time pH>6 (Time(hour) percent when pH >6) / 24(hours) 24 hours No
Secondary % inhibition time gastric pH=4 100-(percent time pH >4) 24 hours No
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