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

PHASE1CompletedINTERVENTIONAL
Enrollment

42

Participants

Timeline

Start Date

March 31, 2013

Primary Completion Date

June 30, 2013

Study Completion Date

August 31, 2013

Conditions
Diarrhea
Interventions
DRUG

Treatment A

Florastor® placebo. Zavesca® capsules dosed at 300 mg daily (one 100 mg capsule three times per day).

DRUG

Treatment B

"Florastor® capsules dosed at 1000 mg daily (two 250 mg capsules two times per day).~Zavesca® capsules dosed at 300 mg daily (one 100 mg capsule three times per day)."

Trial Locations (1)

M9L 3A2

BioPharma Services Inc., Toronto

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Actelion

INDUSTRY

NCT01822028 - Two Period / Two Treatment Cross-over to Assess the Effect of Florastor® on Gastrointestinal Tolerability, Safety, and PK in Healthy Subjects Receiving Zavesca® | Biotech Hunter | Biotech Hunter