Healthy
Conditions
Keywords
Male Subjects
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.
Interventions
DRUGZ-215 10mg
Z-215 10mg, capsules
DRUGZ-215 20mg
Z-215 20mg, capsules
Rabeprazole Sodium 10mg tablets
Rabeprazole Sodium 20mg tablets
Sponsors
Zeria Pharmaceutical
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
20 Years to 45 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 24-Hour Intragastric pH Profile | 4 weeks | Summary statistics of the measurements on Day1 and Day5 of administration are to be calculated by dose. |
| Cmax: Maximum Plasma Concentration for Z-215 | 4 weeks | Summary statistics of pharmacokinetic parameters on Day1 and Day5 of administration are to be calculated by dose. |
| tmax: Time to Reach Maximum Plasma Concentration (Cmax) for Z-215 | 4 weeks | Summary statistics of pharmacokinetic parameters on Day1 and Day5 of administration are to be calculated by dose. |
| t1/2: Terminal Elimination Half-life (t1/2) for Z-215 | 4 weeks | Summary statistics of pharmacokinetic parameters on Day1 and Day5 of administration are to be calculated by dose. |
| Lambda Z: Terminal Elimination Rate Constant (Lambda Z) for Z-215 | 4 weeks | Summary statistics of pharmacokinetic parameters on Day1 and Day5 of administration are to be calculated by dose. |
| AUC0-t: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Z-215 | 4 weeks | Summary statistics of pharmacokinetic parameters on Day1 and Day5 of administration are to be calculated by dose. |
| AUC0-24: Area Under the Plasma Concentration-Time Curve From Time 0 to 24 hour for Z-215 | 4 weeks | Summary statistics of pharmacokinetic parameters on Day1 and Day5 of administration are to be calculated by dose. |
| AUC0-∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Z-215 | 4 weeks | Summary statistics of pharmacokinetic parameters on Day1 and Day5 of administration are to be calculated by dose. |
| CL/F: Apparent Total Body Clearance (CL/F) Pharmacokinetic Parameter for Z-215 | 4 weeks | Summary statistics of pharmacokinetic parameters on Day1 and Day5 of administration are to be calculated by dose. |
| Vd/F: Apparent Volume of Distribution (Vd/F) Pharmacokinetic Parameter for Z-215 | 4 weeks | Summary statistics of pharmacokinetic parameters on Day1 and Day5 of administration are to be calculated by dose. |
| MRT0-∞: Mean Residence Time from Time 0 to Infinity for Z-215 | 4 weeks | Summary statistics of pharmacokinetic parameters on Day1 and Day5 of administration are to be calculated by dose. |
| Rac(Cmax): Accumulation Index of Cmax (Rac(Cmax)) for Z-215 | 4 weeks | Summary statistics of pharmacokinetic parameters on Day1 and Day5 of administration are to be calculated by dose. |
| Rac(AUC): Accumulation Index of AUC (Rac(AUC)) for Z-215 | 4 weeks | Summary statistics of pharmacokinetic parameters on Day1 and Day5 of administration are to be calculated by dose. |
Countries
Japan
Outcome results
None listed