NCT01882296

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

A Block-randomized, Open-Label, Multiple Oral Dosing, Phase I Study to Explore Comparability of the Pharmacodynamics Between S-pantoprazole 10, 20, 40mg and Pantoprazole 20, 40mg in Healthy Male Subjects

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Ahn-Gook Pharmaceuticals Co.,Ltd · Industry
• Sex: Male
• Age: 20 Years – 45 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
DRUG	AGSPT_10	AGSPT 10mg for 7days administration
DRUG	AGSPT_20	AGSPT 20mg for 7days administration
DRUG	AGSPT_40	AGSPT 20mg x 2tablet for 7days administration
DRUG	Pantoprazole_20	Pantoprazole 20mg for 7days administration
DRUG	Pantoprazole_40	Pantoprazole 40mg for 7days administration

Timeline

• Primary completion: 2013-09-01
• First posted: 2013-06-20
• Last updated: 2013-06-20