Investigate a Pharmacokinetics Between S-pantoprazole 20mg and Pantoprazole 40mg in Healthy Male Subjects (S-Pantoprazole)

Ahn-Gook Pharmaceuticals

Status and phase: Unknown; Phase 1

Conditions: Healthy Male Subjects

Treatments: Drug: Pantoloc 40mg; Drug: AGSPT_L20

Study type: Interventional

Funder types: Industry

Identifiers

NCT01821521

AGSPT_L20PK

Details and patient eligibility

About

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

Enrollment: 44 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 ~ 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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44 participants in 2 patient groups

AGSPT_L20

Experimental group

Description:

tablet, q.d.

Treatment:

Drug: AGSPT_L20

Pantoloc 40mg

Active Comparator group

Description:

tablet, q.d.

Treatment:

Drug: Pantoloc 40mg