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The purpose of this study is to assess the pharmacokinetics of rabeprazole under fasting condition.
The purpose of this study is to assess bioequivalence after single administration of the following 4 types of formulation: normal 10 mg rabeprazole tablet rabeprazole, and Type 1, Type 2, and Type 3 granule formulation containing rabeprazole 10 mg.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Experimental |
| |
| 3 | Experimental |
| |
| 4 | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| rabeprazole | Drug | 10 mg normal tablet |
| |
| rabeprazole |
| Measure | Description | Time Frame |
|---|---|---|
| The following pharmacokinetic parameters are calculated: maximum drug concentration (Cmax) in plasma; area under the plasma concentration time curve (AUC) | One day |
| Measure | Description | Time Frame |
|---|---|---|
| Vital signs, clinical laboratory screens of blood and urine, adverse event monitoring, adverse drug reaction monitoring | 13 days |
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Inclusion criteria:
Subjects with homozygous or heterozygous extensive metabolizers of cytochrome P4502C19.
Exclusion criteria:
Subjects with allergy
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| Name | Affiliation | Role |
|---|---|---|
| Kai Shibata | Clinical Research Center, Eisai, Co., Ltd | Study Director |
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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 |
Type 1 granule containing rabeprazole 10 mg |
|
| rabeprazole | Drug | Type 2 granule containing rabeprazole 10 mg |
|
| rabeprazole | Drug | Type 3 granule containing rabeprazole 10 mg |
|
| D011725 |
| Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |