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

Status

UNKNOWN

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01821521

Acronym

S-Pantoprazole

Enrollment

Registered

2013-04-01

Start date

2013-06-30

Completion date

Unknown

Last updated

2013-04-01

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 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

Interventions

DRUGAGSPT_L20

DRUGPantoloc 40mg

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

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 \ 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) * 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
Cmax	0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 24 hours
AUClast	0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 24 hours

Secondary

Measure	Time frame
AUCinf	0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 24 hours
Tmax	0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 24 hours
T1/2β	0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 24 hours

Countries

South Korea

Contacts

Primary ContactSang-Young Yoon

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

Backup ContactCheul-Hun Seong

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

Outcome results

None listed

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