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

Mohammad Hailat; Zainab Zakaraya; Israa Al-Ani; Osaid Al Meanazel; Ramadan Al-Shdefat; Md Khalid Anwer; Mohamed J Saadh; Wael Abu Dayyih

doi:10.3390/ph15020193

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

Pharmaceuticals (Basel). 2022 Feb 3;15(2):193. doi: 10.3390/ph15020193.

Authors

Mohammad Hailat¹, Zainab Zakaraya², Israa Al-Ani², Osaid Al Meanazel³, Ramadan Al-Shdefat⁴, Md Khalid Anwer⁵, Mohamed J Saadh⁶, Wael Abu Dayyih⁷

Affiliations

¹ Faculty of Pharmacy, Al-Zaytoonah University of Jordan, Amman 11733, Jordan.
² Faculty of Pharmacy, Al-Ahliyya Amman University, Amman 19328, Jordan.
³ Michael Sayegh Faculty of Pharmacy, Aqaba University of Technology, Aqaba 77110, Jordan.
⁴ Faculty of Pharmacy, Jadara University, Irbid 21110, Jordan.
⁵ Department of Pharmaceutics, College of Pharmacy, Prince Sattam Bin Abdulaziz University, Al-Kharj 11942, Saudi Arabia.
⁶ Faculty of Pharmacy, Middle East University, Amman 11831, Jordan.
⁷ Faculty of Pharmacy, Mutah University, Al-Karak 61710, Jordan.

Abstract

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.

Keywords: HPLC-MS/MS; adverse effect; bioequivalence; empagliflozin; pharmacokinetics; tablet.