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

NCT ID: NCT02509923

Last Updated: 2016-09-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-07-31
• Study Completion Date: 2016-09-30

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

3-way cross-over, Z-215 10 mg/day / Z-215 20 mg/day / Rabeprazole Sodium 10 mg/day

Group Type: EXPERIMENTAL

Z-215 10mg

Intervention Type: DRUG

Z-215 10mg, capsules

Z-215 20mg

Intervention Type: DRUG

Z-215 20mg, capsules

Rabeprazole Sodium 10mg

Intervention Type: DRUG

Rabeprazole Sodium 10mg tablets

2

3-way cross-over, Z-215 20 mg/day / Z-215 40 mg/day / Rabeprazole Sodium 20 mg/day

Group Type: EXPERIMENTAL

Z-215 20mg

Intervention Type: DRUG

Z-215 20mg, capsules

Rabeprazole Sodium 20mg

Intervention Type: DRUG

Rabeprazole Sodium 20mg tablets

3

3-way cross-over, Z-215 20 mg/day (before breakfast) / Z-215 20 mg/day (after breakfast) / Rabeprazole Sodium 10 mg/day (after breakfast)

Group Type: EXPERIMENTAL

Z-215 20mg

Intervention Type: DRUG

Z-215 20mg, capsules

Rabeprazole Sodium 10mg

Intervention Type: DRUG

Rabeprazole Sodium 10mg tablets

Interventions

Z-215 10mg

Z-215 10mg, capsules

Intervention Type: DRUG

Z-215 20mg

Z-215 20mg, capsules

Intervention Type: DRUG

Rabeprazole Sodium 10mg

Rabeprazole Sodium 10mg tablets

Intervention Type: DRUG

Rabeprazole Sodium 20mg

Rabeprazole Sodium 20mg tablets

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Has negative results for H. pylori IgG antibody at screening.
• A body mass index 18.5≦BMI<25.0 kg/m^2 at screening.
• Able to understand the consent of the study and comply with the study. Able to give informed consent in writing before participating in the study.

Exclusion Criteria

• Has a history of PPI allergy.
• Has a history of drug or food serious allergy.
• Presently has or has a history of diseases that may affect evaluation of the study results such as gastrointestinal, hepatic, renal, respiratory, endocrine, blood, cardiovascular, mental or congenial metabolic disease.
• Has a history of surgery (such as resection of the liver, kidney, or digestive tract) that may affect the pharmacokinetics of the study drug.
• History of previous and current acid-related diseases.
• Received H. pylori eradication treatment within 6 months before screening.
• Has 450msec<QTC by Fridericia test at screening ECG .
• Has hypoacidity or anacidity. Or be determined that low gastric acid or no stomach acid by the gastric pH monitoring at baseline period.
• History or suspicion of drug, opioid, alcohol abuse or positive screening results.
• Use of any prescription drugs within 4 weeks prior to baseline period.
• Use of any over-the-counter drugs within 2 weeks prior to baseline period.
• Received blood transfusions within 12 weeks or donated ≥400mL of whole blood within 12 weeks or ≥200mL of whole blood within 4 weeks prior to baseline period. Donated platelet or plasma within 2 weeks prior to baseline period.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Zeria Pharmaceutical

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Tokyo, , Japan

Countries

Japan

Other Identifiers

Z215-02

Identifier Type: -

Identifier Source: org_study_id