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The purpose of this study is to investigate the bioequivalence of improved and current orally disintegrating E2020 10 mg tablets as a single dose in Japanese healthy adult males for each of two administration methods (with/without water).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| E2020 improved 10 mg without water | Active Comparator |
| |
| E2020 current 10 mg without water | Active Comparator |
| |
| E2020 improved 10 mg with water | Active Comparator |
| |
| E2020 current 10 mg with water | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Donepezil Hydrochloride | Drug | improved orally disintegrating E2020 10 mg tablet without water. |
|
| Measure | Description | Time Frame |
|---|---|---|
| PK Parameter Cmax, calculated from plasma E2020 concentration by a non-compartmental analysis, will be evaluated. | Up to 168 hrs after administration | |
| PK Parameter AUC(0-168), calculated from plasma E2020 concentration by a non-compartmental analysis, will be evaluated. | Up to 168 hrs after administration |
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Inclusion Criteria
Those who meet all below criteria are eligible to enroll in this study;
Exclusion Criteria
Those who meet any of the below criteria will be excluded from the study.
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| Name | Affiliation | Role |
|---|---|---|
| Hiroki Shimizu | Eisai Co., Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sumida-ku | Tokyo | Japan |
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| Donepezil Hydrochloride | Drug | current orally disintegrating E2020 10 mg tablet without water. |
|
| Donepezil Hydrochloride | Drug | improved orally disintegrating E2020 10 mg tablet with water. |
|
| Donepezil Hydrochloride | Drug | current orally disintegrating E2020 10 mg tablet with water |
|
| ID | Term |
|---|---|
| D000077265 | Donepezil |
| ID | Term |
|---|---|
| D007189 | Indans |
| D007192 | Indenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011083 | Polycyclic Compounds |
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