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

NCT ID: NCT01882296

Last Updated: 2013-06-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL

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

Conditions

Healthy Male Subjects

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

AGSPT_10

tablet, 10mg, QD, 7days

Group Type: EXPERIMENTAL

AGSPT_10

Intervention Type: DRUG

AGSPT 10mg for 7days administration

AGSPT_20

tablet, 20mg, QD, 7days

Group Type: EXPERIMENTAL

AGSPT_20

Intervention Type: DRUG

AGSPT 20mg for 7days administration

AGSPT_40

tablet, 20mg x 2, QD, 7days

Group Type: EXPERIMENTAL

AGSPT_40

Intervention Type: DRUG

AGSPT 20mg x 2tablet for 7days administration

Pantoprazole_20

tablet, 20mg, QD, 7days

Group Type: ACTIVE_COMPARATOR

Pantoprazole_20

Intervention Type: DRUG

Pantoprazole 20mg for 7days administration

Pantoprazole_40

tablet, 40mg, QD, 7days

Group Type: ACTIVE_COMPARATOR

Pantoprazole_40

Intervention Type: DRUG

Pantoprazole 40mg for 7days administration

Interventions

AGSPT_10

AGSPT 10mg for 7days administration

Intervention Type: DRUG

AGSPT_20

AGSPT 20mg for 7days administration

Intervention Type: DRUG

AGSPT_40

AGSPT 20mg x 2tablet for 7days administration

Intervention Type: DRUG

Pantoprazole_20

Pantoprazole 20mg for 7days administration

Intervention Type: DRUG

Pantoprazole_40

Pantoprazole 40mg for 7days administration

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Ahn-Gook Pharmaceuticals Co.,Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

AGSPT_PD

Identifier Type: -

Identifier Source: org_study_id