NCT01260155

A Single-Center, Open-Label, Randomized, 3-Treatment Crossover Bioavailability Study of Single Oral Doses of E5501 Old Tablet Formulation Under Fasted Conditions and a New Tablet Formulation Under Fed and Fasted Conditions in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Eisai Inc. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This study will be a single-center, open-label, randomized, 3-treatment crossover bioavailability study of single oral doses of E5501 old tablet formulation under fasted conditions and a new tablet formulation administered under fed and fasted conditions in healthy subjects.

Conditions

• Healthy Subjects

Interventions

Type	Name	Description
DRUG	E5501	Treatment A: 40 mg new tablet formulation (1 tablet) under fasted conditions
DRUG	E5501	Treatment B: 20 mg old tablet formulation (2 tablets) under fasted conditions
DRUG	E5501	Treatment C: 40 mg new tablet formulation administered with food

Timeline

• Start date: 2010-01-01
• Primary completion: 2010-06-01
• Completion: 2010-06-01
• First posted: 2010-12-15
• Last updated: 2013-11-01

Locations

1 site across 1 country: United States