In:
American Journal of Pharmacotherapy and Pharmaceutical Sciences, Scientific Scholar, Vol. 2 ( 2023-11-17), p. 19-
Abstract:
The objective of the study was to evaluate the bioequivalence (BE) between Izaban® (test) and Jardiance® (reference) empagliflozin 25 mg, oral tablets, in healthy adult subjects. Materials and Methods: A randomized, open-label, two-sequence, and two-period crossover comparative oral bioavailability study was conducted on healthy adult subjects. It was tested BE in vivo using a comparative pharmacokinetic (PK) evaluation. Serial blood samples were collected up to 72 h following oral administration of the study drugs, plasma concentrations of empagliflozin were using liquid chromatography mass spectrometry (LC-MS-MS) method. Results: The test and reference drug products were considered bioequivalent when the geometric means of the test (T)/reference (R) ratios and 90% confidence intervals (CIs) fall within the range of 80.00–125.00%. For PK parameters, % T/R ratios and 90% CIs were C max : 105.11% (100.28–110.18%), area under curve (AUC 0-t ): 103.25% (99.62–107.00%), and AUC 0-∞ 102.71% (99.26–106.28%). Conclusion: Our study demonstrated in vivo BE between the two empagliflozin formulations tested in healthy subjects under fasting conditions.
Type of Medium:
Online Resource
ISSN:
2835-253X
,
2836-2012
DOI:
10.25259/AJPPS_2023_019
Language:
English
Publisher:
Scientific Scholar
Publication Date:
2023
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