A unique formulation of sodium bicarbonate buffered pantoprazole powder for oral suspension: perspectives from an active controlled cross-over bioequivalence study
نویسندگان
چکیده
Background: The aim was determining bioequivalence between pantoprazole buffered powder for oral suspension and enteric coated tablets under fasting conditions in healthy volunteers.Methods: In randomized cross-over study, participants were administered a single dose of as 40 mg (sodium bicarbonate buffer) or one tablet mg, with 240±2 ml water per the randomization schedule each study period. Blood samples collected at pre-dose 0.33, 0.67, 1, 1.33, 1.67, 2, 2.33, 2.67, 3, 3.33, 3.67, 4, 4.5, 5, 5.5, 6, 7, 8, 9, 10, 12-, 14-, 16- 24-hours post-dose. Plasma concentration determined LC-MS various pharmacokinetic parameters like Cmax, AUC0-t, AUC0-inf compared test reference groups.Results: Amongst 41 samples, Cmax (3752.4±1084.6 vs. 3521.7±1099.5 ng/ml) achieved higher less Tmax time (1 (0.28) 2.3 (0.83) hrs) drug to drug. ratios geometric least square mean its 90% confidence interval on log transformed AUC0-t fall within acceptance criteria 80% 125%. No adverse events observed.Conclusions: Pantoprazole well tolerated bioequivalent IP terms rate extent absorption conditions. At same time, shift AUC left reduction new formulation is suggestive faster absorption.
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ژورنال
عنوان ژورنال: International Journal of Advances in Medicine
سال: 2022
ISSN: ['2349-3925', '2349-3933']
DOI: https://doi.org/10.18203/2349-3933.ijam20222402