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OpenTrials
Completed

NCT Number: NCT05229796

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

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.

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Key information

Conditions

Pharmacokinetic Parameters

Age range

25 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wael Abu Dayyih

Amman, None Selected, 11196, Jordan

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Empagliflozin 10 mg Tab

Drug

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.

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Mutah University

Other

Registry information

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Feb 8, 2022
Registry last updated
Feb 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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