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

Ahn-Gook Pharmaceuticals

Status and phase: Unknown; Phase 1

Conditions: Healthy Male Subjects

Treatments: Drug: Pantoprazole_20; Drug: AGSPT_10; Drug: AGSPT_40; Drug: AGSPT_20; Drug: Pantoprazole_40

Study type: Interventional

Funder types: Industry

Identifiers

NCT01882296

AGSPT_PD

Details and patient eligibility

About

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

Enrollment: 40 estimated patients

Sex: Male

Ages: 20 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 5 patient groups

AGSPT_10

Experimental group

Description:

tablet, 10mg, QD, 7days

Treatment:

Drug: AGSPT_10

AGSPT_20

Experimental group

Description:

tablet, 20mg, QD, 7days

Treatment:

Drug: AGSPT_20

AGSPT_40

Experimental group

Description:

tablet, 20mg x 2, QD, 7days

Treatment:

Drug: AGSPT_40

Pantoprazole_20

Active Comparator group

Description:

tablet, 20mg, QD, 7days

Treatment:

Drug: Pantoprazole_20

Pantoprazole_40

Active Comparator group

Description:

tablet, 40mg, QD, 7days

Treatment:

Drug: Pantoprazole_40