NCT02509923

To Evaluate Pharmacokinetics and Pharmacodynamics of Z-215 in Healthy Male Subjects

A Randomized, Open-label, Crossover, Pharmacokinetic and Pharmacodynamic Study of Z-215 Compared With Rabeprazole Sodium in Healthy Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: Zeria Pharmaceutical · Industry
• Sex: Male
• Age: 20 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate pharmacokinetics and pharmacodynamics of Z-215 (10 mg, 20 mg, 40 mg) , compared with Rabeprazole Sodium (10 mg, 20 mg ) in Healthy Male Subjects. And to evaluate food-effect in Healthy Male Subjects administrated Z-215 20 mg.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Z-215 10mg	Z-215 10mg, capsules
DRUG	Z-215 20mg	Z-215 20mg, capsules
DRUG	Rabeprazole Sodium 10mg	Rabeprazole Sodium 10mg tablets
DRUG	Rabeprazole Sodium 20mg	Rabeprazole Sodium 20mg tablets

Timeline

• Start date: 2015-07-01
• Primary completion: 2016-03-01
• Completion: 2016-09-01
• First posted: 2015-07-28
• Last updated: 2016-09-22

Locations

1 site across 1 country: Japan