NCT01673880

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

A Single-center, Open-label, Randomized, Multi-cohort, Crossover Study of Relative Bioavailability of Tablet Versus Capsule Formulation of E2006 in Healthy Adult Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Eisai Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Insomnia

Interventions

Type	Name	Description
DRUG	E2006	2.5 mg, 10 mg, and 25 mg E2006 tablets

Timeline

• Start date: 2012-08-01
• Primary completion: 2012-10-01
• Completion: 2012-12-01
• First posted: 2012-08-28
• Last updated: 2013-05-22

Locations

1 site across 1 country: United States