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

• Status: Completed
• Trial end date: 2012-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Eisai Inc.

Criteria

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