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

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.

Timeline

Start

2011-10

Primary completion

2011-11

Completion

2011-11

Drugs

Indications

No indication recorded.