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This is an open-label, single-dose, randomized crossover study of single oral 10-mg tablet doses administered either after an overnight fast or in combination with a standard high-fat meal in healthy subjects.
The study will have 2 phases: Prerandomization and Randomization. The Prerandomization Phase will consist of 2 periods: Screening and Baseline (Baseline Period 1), during which each subject�s study eligibility will be determined and baseline assessments will be conducted. During this phase, each eligible subject will be randomized to 1 of 2 treatment sequences to receive single oral doses of E2006 10 mg under fasted and fed conditions. The Randomization Phase will consist of 3 periods: administration of the first randomized dose (Treatment Period 1), baseline for the second randomized dose (Baseline Period 2), and administration of the second randomized dose (Treatment Period 2).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| E2006: fed conditions | Experimental | E2006 10-mg will be administered as a single dose under fed treatment conditions. |
|
| E2006: fasted conditions | Experimental | E2006 10-mg will be administered as a single dose under fasted treatment conditions. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| E2006 | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics of E2006: AUC(t-0) | Up to Day 15 (336 hours) | |
| Pharmacokinetics of E2006: AUC(t-inf) | Up to Day 15 (336 hours) | |
| Pharmacokinetics of E2006: Maximum Concentration (Cmax) | Up to Day 15 (336 hours) | |
| Pharmacokinetics of E2006: time attain to Cmax (tmax) | Up to Day 15 (336 hours) |
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Inclusion Criteria
Exclusion Criteria
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PPD Development LLC | Austin | Texas | 78744 | United States |
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