NCT05229796

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Mutah University · Academic / Other
• Sex: All
• Age: 25 Years – 40 Years
• Healthy volunteers: Accepted

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.

Conditions

• Pharmacokinetic Parameters

Interventions

Type	Name	Description
DRUG	Empagliflozin 10 mg Tab	The Empagliflozin 10 mg Tab were administered orally. 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 each fasting and fed group.

Timeline

• Start date: 2021-05-17
• Primary completion: 2021-12-10
• Completion: 2021-12-12
• First posted: 2022-02-08
• Last updated: 2022-02-08

Locations

1 site across 1 country: Jordan