Pharmacokinetics and Bioequivalence of Two Empagliflozin, with Evaluation in Healthy Jordanian Subjects under Fasting and Fed Conditions

The current study is a randomized, open-label, two-period, two-sequence, two-way crossover pharmacokinetic study in healthy Jordanian subjects to evaluate the pharmacokinetics and bioequivalence profile of two cases of empagliflozin 10 mg under fasting and fed conditions. The plasma concentrations of empagliflozin were determined using an HPLC-MS/MS method. Tolerability and safety were assessed throughout the study. This study included 26 subjects, 26 in both fasting and fed groups.The pharmacokinetic parameters, which included the area under the concentration-time curve from time zero to infinity (AUC(0-inf)) and the final quantifiable concentration (AUC(0-last)), maximum serum concentration (C-max), and time to reach the maximum drug concentration (T-max) were found to be within an equivalence margin of 80.00-125.00%. The pharmacokinetic profiles show that the empagliflozin test and parent reference cases were bioequivalent in healthy subjects. The two treatments' safety evaluations were also comparable.

Automated summary

This study evaluated the pharmacokinetics and bioequivalence profile of empagliflozin 10 mg under fasting and fed conditions in healthy Jordanian subjects. The results showed that the pharmacokinetic parameters met the bioequivalence criteria and the safety evaluations were comparable.