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

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

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.

Inclusion Criteria:

Inclusion Criteria:

• healthy
• Jordanian volunteers
• some private hospitals (Amman, Jordan) Phase I Clinical Unit

Exclusion Criteria:

• Smokers
• heavy drinkers
• those who used CYP enzyme inhibitors within the previous 60 days
• those who had taken any medicine within the previous four weeks
• those who had a history of medication allergies
• those who had participated in previous clinical studies within the previous six months
• those with any significant clinical abnormality