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| ID | Type | Description | Link |
|---|---|---|---|
| 3144A1-1127 |
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The purpose of the study is to demonstrate the bioequivalence of the proposed commercial neratinib tablet formulation (240 mg strength x 1) to the reference Phase 3 tablet formulation (40 mg tablet strength x 6) under fed and fasted conditions in healthy subjects.
The study will be an open label, randomized, 4 period, 4 treatment, 4 sequence (Williams design), cross over.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment A (Reference fasted) | Treatment A (Reference fasted): A 40 mg tablet strength neratinib administered as a single dose of 6 x 40 mg under fasted condition. |
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| Treatment B (Test fasted) | Treatment B (Test fasted): A 240 mg tablet strength neratinib administered as a single dose of 1 x 240 mg under fasted condition. |
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| Treatment C (Reference fed) | Treatment C (Reference fed): A 40 mg tablet strength neratinib administered as a single dose of 6 x 40 mg under fed condition. |
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| Treatment D (Test fed) | Treatment D (Test fed): A 240 mg tablet strength neratinib administered as a single dose of 1 x 240 mg under fed condition. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neratinib | Drug | Tablet, a 240 mg single oral dose |
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| Measure | Description | Time Frame |
|---|---|---|
| Maximum plasma concentration (Cmax) and Area under the plasma concentration-time profile from time zero extrapolated to infinite time for neratinib (AUCinf) | 0 to 48 hour post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma Time for Cmax (Tmax), Area under the plasma concentration-time profile from time zero to the time of the last quantifiable concentration (Clast) (AUClast) and Terminal elimination half-life (t1/2) for neratinib | 0 to 48 hour post-dose |
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Inclusion Criteria:
Exclusion Criteria:
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Cohorts will be selected from healthy volunteers.
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| Name | Affiliation | Role |
|---|---|---|
| Puma | Biotechnology | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigational Site | New Haven | Connecticut | 06511 | United States |
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| ID | Term |
|---|---|
| C487932 | neratinib |
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Plasma
| Neratinib | Drug | Tablet, a 240 mg single oral dose |
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| Neratinib | Drug | Tablet, a 240 mg single oral dose |
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| Neratinib | Drug | Tablet, a 240 mg single oral dose |
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