NCT01476683

Study to Compare the Pharmacokinetics Profiles of Four Racecadotril Products

An Open-Label, Fasting, Crossover, Single-Dose Pharmacokinetic Study of Four Formulations of Racecadotril

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: McNeil AB · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This study is designed to compare the pharmacokinetics of four products used for treatment of acute diarrhea.

Detailed description

The study will be a single dose, randomized, four -way, four-sequence crossover study in 24 healthy subjects, with equal numbers of males and females (minimum of 10 of either gender). Subjects who drop out will not be replaced. The four doses of medication given in the study (a single dose in each of the four study periods) will be separated by a washout period of at least 7 calendar days. In each study period, 17 blood samples for pharmacokinetic analysis will be taken over 12 hours. Blood samples will be centrifuged and concentrations of thiorphan (the active metabolite) in plasma will be measured using a validated chromatographic assay. Pharmacokinetic parameters will be calculated from plasma concentration data.

Conditions

• Diarrhea

Interventions

Type	Name	Description
DRUG	Racecadotril	Film-coated tablet
DRUG	Racecadotril	Racecadotril Powder Blend
DRUG	Racecadotril	Marketed Capsule
DRUG	Racecadotril	Marketed Film-coated Tablet

Timeline

• Start date: 2011-12-01
• Primary completion: 2011-12-01
• Completion: 2011-12-01
• First posted: 2011-11-22
• Last updated: 2012-07-10

Locations

1 site across 1 country: Canada