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

NCT05229796 | Completed DMC

• 1 other identifier: 17-2021-SRES-4
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• 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.

  5 months

Study Arms (2)

Fasting state

ACTIVE COMPARATOR

Drug: Empagliflozin 10 mg Tab

Fed state

ACTIVE COMPARATOR

Drug: Empagliflozin 10 mg Tab

Interventions

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.

Fasting state; Fed state

Eligibility Criteria

• Age: 25 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• healthy
• Jordanian volunteers
• some private hospitals (Amman, Jordan) Phase I Clinical Unit

You may not qualify if:

• 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

Sponsors & Collaborators

• Mutah University: lead

Study Sites (1)

Wael Abu Dayyih

Amman, None Selected, 11196, Jordan

Location

MeSH Terms

Interventions

empagliflozin

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 18, 2022
• First Posted: February 8, 2022
• Study Start: May 17, 2021
• Primary Completion: December 10, 2021
• Study Completion: December 12, 2021
• Last Updated: February 8, 2022

Record last verified: 2022-01

Locations

JO (1)