drugset / Trial / NCT00655083

A Phase I Study to Evaluate the Oral Absorption of Nepadutant in Infants

NCT00655083 ↗

Phase 1 Completed 21 enrolled Menarini Group
RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of the study is to evaluate the gastrointestinal absorption of nepadutant after single dose as oral solution (and the effect of age on its oral absorption) in infants. Oral absorption is evaluated through the drug recovery in urine.

Timeline

Start
2008-03
Primary completion
2009-05
Completion
2009-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Nepadutant Protein / enzyme biologic 0.1 mg/kg Oral
Subject Nepadutant Protein / enzyme biologic 0.5 mg/kg Oral

Indications

No indication recorded.