The purpose of this study is to determine whether or not consistent drug levels can be achieved in infants with presumed Gastroesophageal Reflux Disease.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
59
Variance of Oral Bioavailability
Samples were divided between 2 groups for each dose: Group A at baseline, 2, 8, 18 hours; Group B at baseline, 1, 4, 12 hours to reduce the number of blood draws per infant. The variance of oral bioavailability was assessed to determine if further PK assessment was appropriate. It would be considered highly variable if the square root of the sum of the standard deviation squares of the area under the concentration-time curves from time zero to the time of the last quantifiable concentration (AUCT) for group A and Group B divided by the sum of the mean AUCT for group A and Group B was \>1.2.
Time frame: 1 day
Area Under the Concentration-time Curve (AUC)
AUC is a measure of the plasma concentration of the drug over time. It is used to characterize drug absorption. AUC was estimated from population pharmacokinetic (PK) modeling.
Time frame: Baseline to 24 hours post dose on Day 1
Apparent Oral Clearance (Cl/F)
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. Clearance was estimated from population pharmacokinetic (PK) modeling.
Time frame: 1 day
Half Life
Half life is the time required for half the quantity of absorbed drug to be metabolized or eliminated by normal biological processes. Half life was estimated from population pharmacokinetic (PK) modeling.
Time frame: 1 day
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Phoenix, Arizona, United States
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Loma Linda, California, United States
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Oakland, California, United States
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Orange, California, United States
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Sacramento, California, United States
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San Diego, California, United States
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New Haven, Connecticut, United States
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Washington D.C., District of Columbia, United States
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Gainesville, Florida, United States
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Miami, Florida, United States
...and 61 more locations