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

January 28, 2022 updated by: Wael Abu Dayyih, Mutah University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

26

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Jordan
    • None Selected
      • Amman, None Selected, Jordan, 11196
        • Wael Abu Dayyih

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Fasting state
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.
Active Comparator: Fed state
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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mutah University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 17, 2021

Primary Completion (Actual)

December 10, 2021

Study Completion (Actual)

December 12, 2021

Study Registration Dates

First Submitted

January 18, 2022

First Submitted That Met QC Criteria

January 28, 2022

First Posted (Actual)

February 8, 2022

Study Record Updates

Last Update Posted (Actual)

February 8, 2022

Last Update Submitted That Met QC Criteria

January 28, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17-2021-SRES-4

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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