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

Status

UNKNOWN

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01882296

Acronym

AGSPT_PD

Enrollment

Registered

2013-06-20

Start date

Unknown

Completion date

Unknown

Last updated

2013-06-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Male Subjects

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

Interventions

DRUGAGSPT_10

AGSPT 10mg for 7days administration

DRUGAGSPT_20

AGSPT 20mg for 7days administration

DRUGAGSPT_40

AGSPT 20mg x 2tablet for 7days administration

DRUGPantoprazole_20

Pantoprazole 20mg for 7days administration

DRUGPantoprazole_40

Pantoprazole 40mg for 7days administration

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

20 Years to 45 Years

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) * 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

Design outcomes

Primary

Measure	Time frame
24h pH	24 hours

Secondary

Measure	Time frame	Description
%Time pH>6	24 hours	(Time(hour) percent when pH \>6) / 24(hours)
% inhibition time gastric pH≤4	24 hours	100-(percent time pH \>4)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026