drugset / Trial / NCT00458614

Pharmacokinetic Study of Lansoprazole in Cystic Fibrosis

NCT00458614

Phase 1 Completed 18 enrolled Arkansas Children's Hospital Research Institute
Non-randomizedSingle-groupOpen-labelTreatment

Summary

The disposition of a number of drugs has been reported to be altered in patients with Cystic Fibrosis (CF). Changes in pharmacokinetic parameters observed included increased volumes of distribution and increased clearance of renally eliminated drugs. The purpose of this this study is to characterize the pharmacokinetics of IV lansoprazole and its metabolites in normal healthy children and children with Cystic Fibrosis (CF) ages 2 to \< 10 years. It is suspected that children with CF will have a more rapid clearance as compared to healthy children.

Timeline

Start
2006-06
Primary completion
2007-04
Completion
2007-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Lansoprazole Other / unclassified Intravenous

Indications