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Bioequivalence Between a Racecadotril Capsule and Film-Coated Tablet (FCT) to Treat Diarrhea in Adults

NCT01302093 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2012-07-10

No results posted yet for this study

Summary

This study is designed to assess bioequivalence between two products used for treatment of acute diarrhea.

Conditions

  • Antidiarrheals

Interventions

DRUG

Racecadotril Film-Coated Tablet (FCT)

A single 100 mg dose of an experimental Racecadotril FCT administered orally with 240 ml of water, with a 7- day washout between visits

DRUG

Racecadotril Capsule

A single 100 mg dose of a marketed Racecadotril capsule administered orally with 240 ml of water, with a 7-day washout between visits

Sponsors & Collaborators

  • McNeil AB

    lead INDUSTRY

Principal Investigators

  • Elisabeth Kruse, PhD · McNeil AB

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2011-01-31
Primary Completion
2011-01-31
Completion
2011-01-31

Countries

  • Canada

Study Locations

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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 NCT01302093 on ClinicalTrials.gov