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Safety and Tolerability of a Single Intra-anal Dose of NRL001 in Healthy Volunteers

Fecal Incontinence Clinical Trial

Official title:
A Randomised, Placebo-controlled, Double-blind, Cross-over Study in Healthy Men and Women to Evaluate the Safety, Tolerability and Pharmacokinetics of Single Intra-anal Doses of NRL001 for Three Doses Using a Cream Formulation Relative to a Matched Placebo Formulation for Reference

Clinical Trial Summary

This study is conducted to explore the safety and tolerability and plasma pharmacokinetics of NRL001 after single intra-anal dose of 1mL cream at increasing concentrations.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01406925
Study type Interventional
Source Norgine
Contact
Status Completed
Phase Phase 1
Start date April 2007
Completion date June 2007
View Details
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