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

• Status: Completed
• Trial end date: 2016-09-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Zeria Pharmaceutical
• Treatments: Rabeprazole

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- 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.