Study Evaluating Pantoprazole in Children With GERD

Maximum Observed Plasma Concentration (Cmax)

Time frame: Predose (0 hour), and 0.5, 1, 2, 4, 6, 12 hours postdose

Time to Reach Maximum Observed Plasma Concentration (Tmax)

Time frame: Predose (0 hour), and 0.5, 1, 2, 4, 6, 12 hours postdose

Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)]

AUC (0-t)= Area under the plasma concentration versus time curve from time zero (predose) to time of last quantifiable concentration (0-t).

Time frame: Predose (0 hour), and 0.5, 1, 2, 4, 6, 12 hours postdose

Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]

AUC (0 - ∞)= Area under the plasma concentration versus time curve (AUC) from time zero (predose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).

Time frame: Predose (0 hour), and 0.5, 1, 2, 4, 6, 12 hours postdose

Plasma Decay Half-Life (t1/2)

Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.

Time frame: Predose (0 hour), and 0.5, 1, 2, 4, 6, 12 hours postdose

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. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.

Time frame: Predose (0 hour), and 0.5, 1, 2, 4, 6, 12 hours postdose

Terminal-Phase Volume of Distribution (Vz/F)