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

NCT01822028 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2015-03-10

No results posted yet for this study

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.

Conditions

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).

Sponsors & Collaborators

  • Actelion

    lead INDUSTRY

Principal Investigators

  • Chad McQueen, PharmD · Actelion

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-03-31
Primary Completion
2013-06-30
Completion
2013-08-31

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01822028 on ClinicalTrials.gov