This longitudinal study tests the hypothesis that obesity affects drug pharmacology of acid suppression medications in children.
The purpose of this research study is to see how the body breaks down certain medicines. Many medicines are broken down in the liver. The liver is an organ in the belly. A person's age, size, genetics (DNA), and the health of their liver decide how quickly the body breaks down medicines and how much medication a person needs to take. Everybody's liver has some fat in it, but the amount of fat is different from person to person. The purpose of this study is to see if the amount of fat in the liver affects how quickly acid suppression medications start and stop working and get removed from the body.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
150
single-dose administration
single-dose administration
Children's Mercy Kansas City
Kansas City, Missouri, United States
plasma pharmacokinetics of pantoprazole
plasma maximum peak concentration (Cmax)
Time frame: 5 years
plasma pharmacokinetics of pantoprazole
area under the concentration time curve (AUC)
Time frame: 5 years
plasma pharmacokinetics of pantoprazole
time to maximum peak concentration (tmax)
Time frame: 5 years
plasma pharmacokinetics of pantoprazole
half-life (t 1/2)
Time frame: 5 years
plasma pharmacokinetics of pantoprazole
volume of distribution (Vd)
Time frame: 5 years
plasma pharmacokinetics of pantoprazole
clearance (CL)
Time frame: 5 years
pharmacodynamics
concentration of gastric acid using pH probe test
Time frame: 5 years
safety of pantoprazole: incidence of reported and gastrointestinal adverse events
incidence of reported and gastrointestinal adverse events
Time frame: 5 years
pharmacokinetics of midazolam, if medication received to ease discomfort of pH probe study
plasma concentrations of midazolam
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Time frame: 5 years
urinary metabolites
urine concentrations of pantoprazole and midazolam and their metabolites
Time frame: 5 years