Open-Label Study of Bioavailability of E2006 Tablet Versus Capsule Formulations
| Status: | Completed |
|---|---|
| Conditions: | Insomnia Sleep Studies |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 11/18/2012 |
| Start Date: | August 2012 |
| End Date: | February 2013 |
| Contact: | Eisai Medical Services |
| Phone: | 1-888-422-4743 |
A Single-center, Open-label, Randomized, Multi-cohort, Crossover Study of Relative Bioavailability of Tablet Versus Capsule Formulation of E2006 in Healthy Adult Subjects
This is a single-center, open-label, randomized crossover study being conducted in three
cohorts of healthy adult subjects. Approximately 36 subjects will be randomized to one of
three cohorts (approximately 12 subjects per cohort) and they will receive both a single
dose of E2006 in capsule formulation and a single dose of E2006 in tablet formulation, in
random sequence, at a 1:1 ratio. The doses to be tested will be 2.5 mg, 10 mg, and 25 mg.
Inclusion:
- Healthy males or females,
- ages 18 to 55 years
- Body mass index (BMI) >
- 18 and 32 kg/m2 at Screening
Exclusion:
- Female subjects who are nursing
- Subjects with a history of gastrointestinal surgery (hepatectomy, nephrectomy,
digestive organ resection, etc.) that may affect PK profiles of E2006
- Subjects with a known history of clinically significant drug or food allergies
- Subjects with a known allergy or hypersensitivity to capsule or tablet ingredients
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