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This is a single center, two-period, randomized study to evaluate the bioequivalence of a single dose of tasimelteon capsule formulation relative to a single dose of liquid suspension formation in healthy volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence A | Experimental | tasimelteon liquid suspension formulation then tasimelteon capsule formulation |
|
| Sequence B | Experimental | tasimelteon capsule formulation then tasimelteon liquid suspension formulation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tasimelteon Oral Capsule | Drug | No additional information |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Bioequivalence between tasimelteon capsule formulation relative to tasimelteon liquid suspension formulation | as measured by plasma concentrations | 8 hours |
| Assessment of Safety and Tolerability of the liquid suspension and capsule formulation of tasimelteon | as measured by incidence of adverse events and clinically significant changes in laboratory values, ECG parameters, and vital signs | 7 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanda Investigational Site | Springfield | Missouri | 65802 | United States |
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| ID | Term |
|---|---|
| C478745 | tasimelteon |
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| Tasimelteon Oral Suspension |
| Drug |
No additional information |
|