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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | 3-way cross-over, Z-215 10 mg/day / Z-215 20 mg/day / Rabeprazole Sodium 10 mg/day |
|
| 2 | Experimental | 3-way cross-over, Z-215 20 mg/day / Z-215 40 mg/day / Rabeprazole Sodium 20 mg/day |
|
| 3 | Experimental | 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Z-215 10mg | Drug | Z-215 10mg, capsules |
| |
| Z-215 20mg |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tokyo | Japan |
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| ID | Term |
|---|---|
| D064750 | Rabeprazole |
| ID | Term |
|---|---|
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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| Drug |
Z-215 20mg, capsules |
|
| Rabeprazole Sodium 10mg | Drug | Rabeprazole Sodium 10mg tablets |
|
| Rabeprazole Sodium 20mg | Drug | Rabeprazole Sodium 20mg tablets |
|
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 |
| D011725 |
| Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |