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Pharmacokinetics of Esomeprazole Magnesium After Single Oral Doses in Healthy Subjects: Bioequivalence Study and Food Effects.
- Source :
-
Clinical pharmacology in drug development [Clin Pharmacol Drug Dev] 2022 Nov; Vol. 11 (11), pp. 1308-1313. Date of Electronic Publication: 2022 Jul 13. - Publication Year :
- 2022
-
Abstract
- This study was designed to evaluate the bioequivalence of the newly developed delayed-release oral suspension (test) 40 mg esomeprazole magnesium compared to its marketed counterpart (40 mg; reference) in healthy adult Chinese subjects. We conducted randomized, open-label, two-period, single-dose, two-way crossover trials over a 7-day washout period, comprising a fasting trial and a fed trial. The subjects were administered the test or reference products in a 1:1 ratio at random throughout each period. Then, in the next session, they received the alternate products. Liquid chromatography-tandem mass spectrometry and WinNonlin software were used to assess the bioequivalence of esomeprazole peak plasma concentration (C <subscript>max</subscript> ) and area under the concentration-time curve (AUC). Overall, 33 subjects participated in the fasting trial and 42 subjects participated in the fed trial. Under both situations, the 90% confidence interval for the ratio of geometric means of C <subscript>max</subscript> , AUC <subscript>0-t</subscript> , and AUC <subscript>0-∞</subscript> were within equivalence ranges (80%-125%). In these trials, no severe adverse events or protocol violations were observed. Moreover, when esomeprazole was administered while fed, the t <subscript>max</subscript> was delayed, and both C <subscript>max</subscript> and AUC were reduced. The results of this research suggest that the test and reference formulations were bioequivalent under fasting and fed states.<br /> (© 2022, The American College of Clinical Pharmacology.)
Details
- Language :
- English
- ISSN :
- 2160-7648
- Volume :
- 11
- Issue :
- 11
- Database :
- MEDLINE
- Journal :
- Clinical pharmacology in drug development
- Publication Type :
- Academic Journal
- Accession number :
- 35822412
- Full Text :
- https://doi.org/10.1002/cpdd.1139