NCT01302093

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

A Two-Way Crossover, Open-Label, Single-Dose, Fasting, Bioequivalence Study of Racecadotril 100 mg FCT Versus Tiorfast® 100 mg Capsules, in Normal, Healthy, Non-Smoking Male and Female Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: McNeil AB · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

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

Detailed description

The study will be a single dose, randomized, two-way crossover study in 40 healthy subjects, with equal numbers of males and females (minimum of 18 of either gender). Drop-outs will not be replaced. The two doses of medication given in the study (a single dose in each of the two study periods) will be separated by a washout period of at least 7 calendar days. In each study period, twenty (20) blood samples for pharmacokinetic analysis and, for the first 8 male and 8 female subjects included in the study (total of 16 subjects), seven (7) blood samples for pharmacodynamic analysis will be taken over 24 hours. Blood samples will be centrifuged and concentrations of thiorphan in plasma will be measured using a validated chromatographic assay. Pharmacokinetic parameters will be calculated from plasma concentration data. The rate and extent of absorption of the formulations will be compared.

Conditions

• Antidiarrheals

Interventions

Type	Name	Description
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

Timeline

• Start date: 2011-01-01
• Primary completion: 2011-01-01
• Completion: 2011-01-01
• First posted: 2011-02-23
• Last updated: 2012-07-10

Locations

1 site across 1 country: Canada