Overview

Two Period / Two Treatment Cross-over to Assess the Effect of Florastor® on Gastrointestinal Tolerability, Safety, and PK in Healthy Subjects Receiving Zavesca®

Status:
Completed

Trial end date:
2013-08-01

Target enrollment:

Participant gender:

Summary

Cross-over, tolerability study with healthy subjects taking Zavesca in combination with Florastor. Forty-two subjects will be randomized to one of two treatment sequences of Zavesca with Florastor and Zavesca with Placebo of Florastor. Gastrointestinal tolerability and PK endpoints, demographic, laboratory and safety testing, and AEs and SAEs will be collected throughout the seventy-four day study.

Phase:

Phase 1

Details

Lead Sponsor:

Actelion

Treatments:

1-Deoxynojirimycin
Miglustat