Pharmacokinetics and Bioequivalence of Two Empagliflozin, With Evaluation in Healthy Jordanian Subjects Under Fasting and Fed Conditions

Pharmacokinetic Parameters Clinical Trial

Official title: Pharmacokinetics and Bioequivalence of Two Empagliflozin, With Evaluation in Healthy Jordanian Subjects Under Fasting and Fed Conditions

Status Completed

Clinical Trial Summary

Background: 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 formulations of empagliflozin 10-mg under fasting and fed conditions administered orally.; (2) Methods: The plasma concentrations of empagliflozin were determined using High-performance liquid chromatography- Mass Spectrometry/ Mass Spectrometry (HPLC-MS/MS) method. This study included 26 subjects, 26 in each fasting and fed group.

Clinical Trial Description

n/a

• NCT number: NCT05229796
• Study type: Interventional
• Source: Mutah University
• Status: Completed
• Phase: N/A
• Start date: May 17, 2021
• Completion date: December 12, 2021