Open-Label Study of Bioavailability of E2006 Tablet Versus Capsule Formulations

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-31

Study Completion Date

2012-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Insomnia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

* 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes