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

NCT05229796 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2022-02-08

No results posted yet for this 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

  • Pharmacokinetic Parameters

Interventions

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.

Sponsors & Collaborators

  • Mutah University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
25 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-05-17
Primary Completion
2021-12-10
Completion
2021-12-12

Countries

  • Jordan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05229796 on ClinicalTrials.gov