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

Mutah University

Status: Completed

Conditions: Pharmacokinetic Parameters

Treatments: Drug: Empagliflozin 10 mg Tab

Study type: Interventional

Funder types: Other

Identifiers

NCT05229796

17-2021-SRES-4

Details and patient eligibility

About

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.

Enrollment: 26 patients

Sex: All

Ages: 25 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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26 participants in 2 patient groups

Fasting state

Active Comparator group

Treatment:

Drug: Empagliflozin 10 mg Tab

Fed state

Active Comparator group

Treatment:

Drug: Empagliflozin 10 mg Tab