35761
document
Comparative bioavailability study with two pantoprazole delayed-released tablet formulations administered with and without food in healthy subjects . 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 AUC ( last ) and C ( max ) 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 % -109.8275 % ) for C ( max ) , 95.6634 % ( 85.2675 % -107.3267 % ) and 89.3500 % ( 83.6630 % -95.4237 % ) for AUC ( last ) . CONCLUSION Since the 90 % CI for AUC ( last ) and C ( max ) 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 .
35762
Intervention_Pharmacological
pantoprazole
35763
Intervention_Pharmacological
( 40 mg delayed-released [ DR ] tablet ; test and reference ) of pantoprazole
35764
Intervention_Pharmacological
pantoprazole
35765
Intervention_Pharmacological
pantoprazole
35766
Intervention_Pharmacological
pantoprazole
35767
Outcome_Other
comparative bioavailability
35768
Outcome_Other
limit of quantification
35769
Outcome_Other
geometric mean and 90 % confidence interval CI of test/reference percent ratios
35770
Outcome_Other
C ( max )
35771
Outcome_Other
AUC ( last )
35772
Outcome_Other
C ( max ) ratios