CompletedNCT05229796Updated Feb 8, 2022

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

An interventional study of Empagliflozin 10 mg Tab in Pharmacokinetic Parameters, sponsored by Mutah University. Completed at 1 site in Jordan. Open to participants aged 25 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-02-08.

Sponsored by Mutah University · Not applicable, Interventional, and Basic science

From the registry’s dates

Registered 8 months after the study started (first participant enrolled May 2021, registered Jan 2022).

Phase: Not applicable
Study type: Interventional
Enrollment: 26
Allocation: Randomized
Ages: 25 Years to 40 Years
Sex: All

Study 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 studied

Pharmacokinetic Parameters

In context

Lead sponsor

Mutah University is the lead sponsor of 7 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 25 Years to 40 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

Eligibility 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

Study design

Phase: Not applicable
Primary purpose: Basic science
Allocation: Randomized
Intervention model: Crossover assignment
Masking: Double (Participant, Care provider)
Enrollment: 26 participants (actual)

Study arms

Active comparator
Fasting state
Drug: Empagliflozin 10 mg Tab
Active comparator
Fed state
Drug: Empagliflozin 10 mg Tab

Interventions

DrugEmpagliflozin 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.

What researchers measure

Primary outcomes

The plasma concentrations of empagliflozin were determined using an HPLC-MS/MS method.
The plasma concentration of empagliflozin under fasting and fed conditions states were measured using HPLC-MS/MS method and recorded in nmol\\L.
Time frame: 5 months

Study locations

1 site

Wael Abu Dayyih
Amman, None Selected 11196, Jordan

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Feb 8, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT05229796
Lead sponsor: Mutah University
Responsible party: Wael Abu Dayyih (Professor, Mutah University) — Principal investigator
First posted: Feb 8, 2022
Start date: May 17, 2021
Primary completion: Dec 10, 2021
Completion: Dec 12, 2021
Last update: Feb 8, 2022

Oversight

Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.

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