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Lansoprazole Disposition in Young Children With Cystic Fibrosis

ClinicalTrials.gov · COMPLETED, 2007

18 participants

Abstract

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.

Conditions: Cystic Fibrosis.

Primary outcome: Examine the PK enantiomers of IV lansoprazole and metabolites, in normal children and children with CF..

Enrollment: 18 participants.

How strong is the evidence?

Evidence Hub reads this as a clinical trial, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 18 participants or records.

How the five levels of evidence work. The level is assigned automatically from the abstract and can be wrong, so check the paper.

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