A Phase 1, Randomized, Open-Label, Parallel Design, Multicenter Study to Evaluate the Pharmacokinetics and Safety of Dexlansoprazole Delayed Release Capsules in Pediatric Subjects Ages 1 to 11 Years Old With Symptomatic Gastroesophageal Reflux Disease
Abstract
The purpose of this study is to assess the pharmacokinetics and safety of dexlansoprazole, once daily (QD), in pediatric subjects with symptomatic Gastroesophageal Reflux Disease.
Conditions: Gastroesophageal Reflux.
Primary outcome: Time to Reach the Peak Plasma Concentration (Tmax); The Peak Plasma Concentration (Cmax); Area Under the Plasma Concentration Versus Time Curve (AUC) From Time 0 to Time of the Last Quantifiable Concentration (AUC(0-tlqc)); Area Under the Plasma Concentration Versus Time Curve (AUC) From Time 0 to 24 Hours Post-dose (AUC(0-24)).
Enrollment: 36 participants.
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 36 participants or records.
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