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This study will be a single-center, open-label, randomized, 3-treatment crossover bioavailability study of single oral doses of E5501 old tablet formulation under fasted conditions and a new tablet formulation administered under fed and fasted conditions in healthy subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment A Fasted | Experimental |
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| Treatment B Fasted | Experimental |
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| Treatment C Food Effect | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| E5501 | Drug | Treatment A: 40 mg new tablet formulation (1 tablet) under fasted conditions |
|
| Measure | Description | Time Frame |
|---|---|---|
| To determine the bioavailability (BA) of E5501 in one 40 mg new tablet formulation relative to two 20 mg old tablet formulation. | 2 months |
| Measure | Description | Time Frame |
|---|---|---|
| To determine the effect of a high fat meal on the BA of E5501 in one 40 mg new tablet formulation | 2 months | |
| To evaluate the safety of E5501 in healthy subjects. | 2 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Franklin Johnson | Eisai Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Celerion | Phoenix | Arizona | United States |
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| E5501 | Drug | Treatment B: 20 mg old tablet formulation (2 tablets) under fasted conditions |
|
| E5501 | Drug | Treatment C: 40 mg new tablet formulation administered with food |
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| ID | Term |
|---|---|
| C533238 | avatrombopag |
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