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Investigate a Pharmacokinetics Between S-pantoprazole 20mg and Pantoprazole 40mg in Healthy Male Subjects | Clinical Trials | Clareo Health

UNKNOWNPHASE1

Investigate a Pharmacokinetics Between S-pantoprazole 20mg and Pantoprazole 40mg in Healthy Male Subjects

A Randomized, Open Label, Single-dose, 2x2 Crossover Study to Investigate a Pharmacokinetics Between S-pantoprazole 20mg and Pantoprazole 40mg in Healthy Male Subjects

NCT01821521•Ahn-Gook Pharmaceuticals Co.,Ltd

View on ClinicalTrials.gov

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 and Pantoprazole 40mg in healthy male subjects

Eligibility

Age

20 - 45 years

Sex

MALE

Healthy Volunteers

Yes

Inclusion Criteria

•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 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
•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)
+2 more criteria

Locations (1)

Asan Medical Center

Seoul, South Korea

Key Dates

Start Date

June 1, 2013

Primary Completion Date

August 1, 2013

Last Updated

April 1, 2013

Enrollment

ESTIMATED participants

Conditions

Healthy Male Subjects

Interventions

AGSPT_L20

DRUG

Pantoloc 40mg

DRUG

Contacts

Sang-Young Yoon

CONTACT

+82-2-3289-4257 agcntechpp@ahn-gook.com

Cheul-Hun Seong

CONTACT

+82-2-3289-4284 agcntechpp@ahn-gook.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 1, 2013Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Investigate a Pharmacokinetics Between S-pantoprazole 20mg and Pantoprazole 40mg in Healthy Male Subjects

Inclusion Criteria

Exclusion Criteria

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