NCT01452542View on ClinicalTrials.gov

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

PHASE1CompletedINTERVENTIONAL
Enrollment

22

Participants

Timeline

Start Date

October 31, 2011

Primary Completion Date

November 30, 2011

Study Completion Date

November 30, 2011

Conditions
Healthy Volunteer
Interventions
DRUG

Eliglustat, common blend proposed commercial formulation

All participants will receive a single oral 150-mg dose of the common blend proposed commercial formulation of eliglustat, administered as one 150-mg strength capsule (Treatment T), on 2 separate dosing occasions.

DRUG

Eliglustat, Phase 3 capsule formulation

All participants will receive a single oral 150-mg dose of the Phase 3 capsule formulation of eliglustat, administered as three 50-mg strength capsules (Treatment R), on 2 separate dosing occasions.

Trial Locations (1)

Unknown

PPD Phase 1 Unit, Austin

All Listed Sponsors
lead

Genzyme, a Sanofi Company

INDUSTRY

NCT01452542 - 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 | Biotech Hunter | Biotech Hunter