Overview

A Phase I Study of the Pharmacokinetic Variability and Relative Bioavailability of the Phase 3 and Common Blend Formulations of Eliglustat in Healthy Adult Subjects

Status:
Completed

Trial end date:
2011-11-01

Target enrollment:

Participant gender:

Summary

The primary objective of this pilot study is to determine the within-subject pharmacokinetic (PK) variability and relative bioavailability of single oral 150-mg doses of eliglustat administered as the Phase 3 formulation (3x50-mg capsules) and the common blend proposed commercial formulation (1x150-mg capsule) in healthy adult subjects, which will be used to plan and support the design of a subsequent bioequivalence study.

Phase:

Phase 1

Details

Lead Sponsor:

Genzyme, a Sanofi Company

Treatments:

Eliglustat