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

Phase 1

• Conditions: Healthy Male Subjects
• Interventions: Drug: AGSPT_L20; Drug: Pantoloc 40mg

• Registration Number: NCT01821521
• Lead Sponsor: Ahn-Gook Pharmaceuticals Co.,Ltd

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2013-03
• Study First Submitted: 2013-03-25
• Study First Submitted QC: 2013-03-29
• Last Update Submitted: 2013-03-29
• Study First Posted: 2013-04-01
• Last Update Posted: 2013-04-01
• Study Start: 2013-06
• Primary Completion: 2013-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 44

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
AGSPT_L20	AGSPT_L20	tablet, q.d.
Pantoloc 40mg	Pantoloc 40mg	tablet, q.d.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of