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

Study Overview
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Brief Summary
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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.

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

Conditions
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Healthy

Intervention / Treatment
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* Drug: Z-215 10mg
* Drug: Z-215 20mg
* Drug: Rabeprazole Sodium 10mg
* Drug: Rabeprazole Sodium 20mg


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>3-way cross-over, Z-215 10 mg/day / Z-215 20 mg/day / Rabeprazole Sodium 10 mg/day | Drug: Z-215 10mg<br>* Z-215 10mg, capsules<br>Drug: Z-215 20mg<br>* Z-215 20mg, capsules<br>Drug: Rabeprazole Sodium 10mg<br>* Rabeprazole Sodium 10mg tablets<br>|
| Experimental: 2<br>3-way cross-over, Z-215 20 mg/day / Z-215 40 mg/day / Rabeprazole Sodium 20 mg/day | Drug: Z-215 20mg<br>* Z-215 20mg, capsules<br>Drug: Rabeprazole Sodium 20mg<br>* Rabeprazole Sodium 20mg tablets<br>|
| Experimental: 3<br>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) | Drug: Z-215 20mg<br>* Z-215 20mg, capsules<br>Drug: Rabeprazole Sodium 10mg<br>* Rabeprazole Sodium 10mg tablets<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 24-Hour Intragastric pH Profile | Summary statistics of the measurements on Day1 and Day5 of administration are to be calculated by dose. | 4 weeks | 
| Cmax: Maximum Plasma Concentration for Z-215 | Summary statistics of pharmacokinetic parameters on Day1 and Day5 of administration are to be calculated by dose. | 4 weeks | 
| tmax: Time to Reach Maximum Plasma Concentration (Cmax) for Z-215 | Summary statistics of pharmacokinetic parameters on Day1 and Day5 of administration are to be calculated by dose. | 4 weeks | 
| t1/2: Terminal Elimination Half-life (t1/2) for Z-215 | Summary statistics of pharmacokinetic parameters on Day1 and Day5 of administration are to be calculated by dose. | 4 weeks | 
| Lambda Z: Terminal Elimination Rate Constant (Lambda Z) for Z-215 | Summary statistics of pharmacokinetic parameters on Day1 and Day5 of administration are to be calculated by dose. | 4 weeks | 
| AUC0-t: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Z-215 | Summary statistics of pharmacokinetic parameters on Day1 and Day5 of administration are to be calculated by dose. | 4 weeks | 
| AUC0-24: Area Under the Plasma Concentration-Time Curve From Time 0 to 24 hour for Z-215 | Summary statistics of pharmacokinetic parameters on Day1 and Day5 of administration are to be calculated by dose. | 4 weeks | 
| AUC0-∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Z-215 | Summary statistics of pharmacokinetic parameters on Day1 and Day5 of administration are to be calculated by dose. | 4 weeks | 
| CL/F: Apparent Total Body Clearance (CL/F) Pharmacokinetic Parameter for Z-215 | Summary statistics of pharmacokinetic parameters on Day1 and Day5 of administration are to be calculated by dose. | 4 weeks | 
| Vd/F: Apparent Volume of Distribution (Vd/F) Pharmacokinetic Parameter for Z-215 | Summary statistics of pharmacokinetic parameters on Day1 and Day5 of administration are to be calculated by dose. | 4 weeks | 
| MRT0-∞: Mean Residence Time from Time 0 to Infinity for Z-215 | Summary statistics of pharmacokinetic parameters on Day1 and Day5 of administration are to be calculated by dose. | 4 weeks | 
| Rac(Cmax): Accumulation Index of Cmax (Rac(Cmax)) for Z-215 | Summary statistics of pharmacokinetic parameters on Day1 and Day5 of administration are to be calculated by dose. | 4 weeks | 
| Rac(AUC): Accumulation Index of AUC (Rac(AUC)) for Z-215 | Summary statistics of pharmacokinetic parameters on Day1 and Day5 of administration are to be calculated by dose. | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Male Subjects