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

NCT02509923 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2016-09-22

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Zeria Pharmaceutical

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
20 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-07-31
Primary Completion
2016-03-31
Completion
2016-09-30

Countries

  • Japan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02509923 on ClinicalTrials.gov