A Phase 1, Randomized, Open-Label, Parallel Group, Multicenter Study to Evaluate the Pharmacokinetics and Safety of Dexlansoprazole Modified Release Capsules (30 mg and 60 mg) in Adolescents With Symptomatic Gastroesophageal Reflux Disease
Abstract
The purpose of this study is to asses the pharmacokinetics and safety of dexlansoprazole modified release (MR), once daily (QD), in adolescent subjects (age 12-17 years old) with Symptomatic Gastroesophageal Reflux Disease.
Conditions: Gastroesophageal Reflux.
Primary outcome: Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) Pharmacokinetic Parameter; Cmax: Maximum Observed Plasma Concentration Pharmacokinetic Parameter.; AUC(0-tlqc): Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration Pharmacokinetic Parameter.; AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours Postdose Pharmacokinetic Parameter.; Terminal Phase Elimination Half-life (T1/2) Pharmacokinetic Parameter.; Oral Clearance (CL/F) Pharmacokinetic Parameter.; Terminal Elimination Rate Constant (λz) Pharmacokinetic Parameter.; Apparent Volume of Distribution (Vz/F) Pharmacokinetic Parameter..
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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