Pharmacokinetics
Conditions
Keywords
pediatrics, neonates
Brief summary
The purpose of this research study is to evaluate how much of repeated once daily intravenous (IV, meaning through a vein) doses of esomeprazole gets into the bloodstream of hospitalized children aged 0-17 years old that require acid suppression therapy.
Interventions
DRUGesomeprazole
IV qd for 4 days
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 17 Years
Healthy volunteers
No
Inclusion criteria
* parent/guardian must sign consent form and the child will be asked to sign and Assent Form if he/she is old enough and is able to sign * verbal assent will be acceptable if the child is old enough to understand, but unable to write * female and/or male hospitalized patients aged 0-17 years old who should be considered for treatment with acid suppressive therapy.
Exclusion criteria
* female patients that are pregnant, or plan to become pregnant during the study period or is breast-feeding a child * patients with a history of multiple drug allergies * any illness, medical history, abnormal laboratory values, abnormal physical examination findings or abnormal vitals signs that could put the patient at risk when participating in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetic-area under plasma concentration versus time curve within a dosing interval | Day 4 of study |
Secondary
| Measure | Time frame |
|---|---|
| Maximum plasma concentration, total, plasma clearance, steady-state volume of distribution of esomeprazole | Day 4 of study |
| Safety and tolerability will be assessed by AEs, laboratory values, blood pressure, heart rate, respiratory rate, body temperature, and ECG | Days 1-4 (during treatment), Days 1-28 (post treatment) |
| Evaluate main metabolites of esomeprazole (sulphone metabolite and 5-hydroxy metabolite) by assessment of max plasma conc, total area under the plasma concentration vs time curve within a dosing interval, clearance scaled by fraction metabolised | Day 4 |
Countries
Australia, Belgium, Hungary, Sweden, United States
Outcome results
None listed