NCT01289509

A Study to Evaluate the Relative Bioavailability and Intra-Subject Variability of Two Lots of E5501 40 mg Tablets Administered Twice as Single Oral Doses to Healthy Subjects

A Randomized, Open-Label, 4-Way Crossover Replicate Design Study to Evaluate the Relative Bioavailability and Intra-Subject Variability of Two Lots of E5501 40 mg Tablets Administered Twice as Single Oral Doses to Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: Eisai Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the relative bioavailability (BA) of two lots of E5501 40 mg tablets administered twice as single oral doses to healthy subjects.

Detailed description

This is a randomized, open label, 4- way crossover, replicate design study to evaluate the bioavailability (BA) of E5501 new Phase 3 formulation Lot P97001ZZB 40 mg tablet manufactured July, 2009 (Treatment A ,reference drug) relative to Lot P01010ZZA 40 mg tablet manufactured January, 2010 (Treatment B, test drug) administered to 42 healthy male and female subjects.

Conditions

• Idiopathic Thrombocytopenia Purpura

Interventions

Type	Name	Description
DRUG	E5501	Lot P01010ZZA (test) single oral doses of 40 mg tablets.
DRUG	Drug: E5501	Lot P97001ZZB (reference) single oral doses of 40 mg tablets.

Timeline

• Start date: 2010-12-01
• Primary completion: 2011-03-01
• Completion: 2011-05-01
• First posted: 2011-02-03
• Last updated: 2013-11-01

Locations

1 site across 1 country: United States