Summary
Objective:
To assess the comparative bioavailability of two formulations (40 mg delayed-released
[DR] tablet; test and reference) of pantoprazole (CAS 102625-70-7) in healthy volunteers
of both sexes, with and without food.
Methods:
The study was conducted using an open, randomized, two-period crossover design with
a 1-week washout interval, in two groups, with and without food. Plasma samples were
obtained for up to 24 h post dose. Plasma pantoprazole concentrations were analyzed
by liquid chromatography coupled to tandem mass spectrometry (LC-MS-MS) with positive
ion electrospray ionization using multiple reactions monitoring (MRM). From the pantoprazole
plasma concentration vs. time curves, the pharmacokinetic parameters AUClast and Cmax were obtained, with and without food.
Results:
The limit of quantification was 5 ng/mL for plasma pantoprazole analysis. The geometric
mean and 90% confidence interval CI of test/reference percent ratios were, without
and with food, respectively: 104.6540% (90.8616%–120.5401%) and 99.9708% (90.9987%–l09.8275%)
for Cmax, 95.6634% (85.2675%–107.3267%) and 89.3500% (83.6630%–95.4237%) for AUClast.
Conclusion:
Since the 90% CI for AUClast and Cmax ratios were within the 80–125% interval proposed by the US FDA, it was concluded
that pantoprazole 40 mg DR tablet (test formulation) with and without food was bioequivalent
to the reference 40 mg DR tablet for both the rate and extent of absorption.
Key words
CAS 102625-70-7 - Pantoprazole, bioavailability, bioequivalence, effect of food, -
pharmacokinetics, quantification method - Proton pump inhibitors
