The purpose of this study is to characterize the pharmacokinetic (PK) and pharmacodynamic (PD) profiles to determine the safety and tolerability of single and multiple doses of pantoprazole in infants aged 1 through 11 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
67
pediatric suspension taken daily x 7 days
Unnamed facility
Little Rock, Arkansas, United States
Peak Concentration (Cmax)
Pharmacokinetic (PK) parameters, including peak plasma concentration, were determined following a single oral dose of pantoprazole
Time frame: 1 day
Time to Peak Concentration (Tmax) Profile
Pharmacokinetic (PK) parameters, including time to peak plasma concentration, were determined following a single oral dose of pantoprazole.
Time frame: 1 day
Disposition Half-life
Pharmacokinetic (PK) parameters, including the terminal-phase disposition half-life, were determined following a single oral dose of pantoprazole. Half-life is the time required for half the quantity of absorbed drug to be metabolized or eliminated by normal biological processes.
Time frame: 1 day
Area Under the Concentration-time Curve (AUC)
Pharmacokinetic (PK) parameters, including AUC, were determined following a single oral dose of pantoprazole. AUC is a measure of the plasma concentration of the drug over time. It is used to characterize drug absorption.
Time frame: 1 day
Apparent Oral Clearance (CL/F)
Pharmacokinetic (PK) parameters, including apparent oral clearance, were determined following a single oral dose of pantoprazole. Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed.
Time frame: 1 day
Pantoprazole Plasma Concentration After Multiple-Dose Oral Administration
Plasma concentration of pantoprazole after multiple doses was measured to see if there was any accumulation of the drug.
Time frame: 7 days
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Unnamed facility
Loma Linda, California, United States
Unnamed facility
San Diego, California, United States
Unnamed facility
Washington D.C., District of Columbia, United States
Unnamed facility
Miami, Florida, United States
Unnamed facility
Pensacola, Florida, United States
Unnamed facility
Chicago, Illinois, United States
Unnamed facility
Park Ridge, Illinois, United States
Unnamed facility
Louisville, Kentucky, United States
Unnamed facility
Shreveport, Louisiana, United States
...and 21 more locations
Intragastric pH
Intragastric pH is a method for evaluating gastric acidity scaled 0-9. A lower pH means more acidity. A longer duration of esophageal mucosa exposure to a gastric refluxate with a pH \<4.0 correlates with more severe mucosal injury in patients with gastroesophageal reflux disease (GERD).
Time frame: 7 days
Median Intragastric pH
Intragastric pH is a method for evaluating gastric acidity scaled 0-9. A lower pH means more acidity. A longer duration of esophageal mucosa exposure to a gastric refluxate with a pH \<4.0 correlates with more severe mucosal injury in patients with gastroesophageal reflux disease (GERD).
Time frame: 7 days
Percentage of Time Intragastric pH Was >4
Intragastric pH is a method for evaluating gastric acidity. A lower pH means more acidity. A longer duration of esophageal mucosa exposure to a gastric refluxate with a pH \<4.0 correlates with more severe mucosal injury in patients with gastroesophageal reflux disease (GERD).
Time frame: 7 days
Mean Intraesophageal pH
Intraesophagel pH is a method for evaluating acidity of gastric refluxate scaled 0-9. A lower pH means more acidity. A longer duration of esophageal mucosa exposure to a gastric refluxate with a pH \<4.0 correlates with more severe mucosal injury in patients with gastroesophageal reflux disease (GERD).
Time frame: 7 days
Median Intraesophageal pH
Intraesophagel pH is a method for evaluating acidity of gastric refluxate scaled 0-9. A lower pH means more acidity. A longer duration of esophageal mucosa exposure to a gastric refluxate with a pH \<4.0 correlates with more severe mucosal injury in patients with gastroesophageal reflux disease (GERD).
Time frame: 7 days
Percentage of Time That Intraesophageal pH Was <4
Intraesophagel pH is a method for evaluating acidity of gastric refluxate. A lower pH means more acidity. A longer duration of esophageal mucosa exposure to a gastric refluxate with a pH \<4.0 correlates with more severe mucosal injury in patients with gastroesophageal reflux disease (GERD).
Time frame: 7 days
Normalized Area of Gastric Hydrogen Ion Activity Over Time
Normalized Area of Gastric Hydrogen Ion Activity Over Time is a measure of the area under the curve of the gastric hydrogen ion activity over time, which is normalized for a 24-hour period.
Time frame: 7 days
Normalized Area of Esophageal Hydrogen Ion Activity Over Time
Normalized Area of Esophageal Hydrogen Ion Activity Over Time is a measure of the area under the curve of the esophageal hydrogen ion activity over time, which is normalized for a 24-hour period.
Time frame: 7 days