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

• Status: Completed
• Trial end date: 2021-12-12
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Mutah University
• Treatments: Empagliflozin

Criteria

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