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Investigate a Pharmacodynamics Between S-pantoprazole 10, 20, 40mg and Pantoprazole 20, 40mg in Healthy Male Subjects | Clinical Trials | Clareo Health

UNKNOWNPHASE1

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

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

NCT01882296•Ahn-Gook Pharmaceuticals Co.,Ltd

View on ClinicalTrials.gov

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

Eligibility

Age

20 - 45 years

Sex

MALE

Healthy Volunteers

Yes

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)
+2 more criteria

Key Dates

Primary Completion Date

September 1, 2013

Last Updated

June 20, 2013

Enrollment

ESTIMATED participants

Conditions

Healthy Male Subjects

Interventions

AGSPT_10

DRUG

AGSPT_20

DRUG

AGSPT_40

DRUG

Pantoprazole_20

DRUG

Pantoprazole_40

DRUG

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

Inclusion Criteria

Exclusion Criteria

Study to Compare the Pharmacokinetics, Pharmacodynamics, Safety, Tolerability, and Immunogenicity of Biosimilar Denosumab With Prolia® in Healthy Adult Male Volunteers

A Study of PET/CT Imaging Using INR101 Injection in Healthy Male Subjects and Patients With Suspected Prostate Cancer

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