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

Study Overview
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Brief Summary
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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.

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

Conditions
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Pharmacokinetic Parameters

Intervention / Treatment
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* Drug: Empagliflozin 10 mg Tab


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Fasting state<br> | Drug: Empagliflozin 10 mg Tab<br>* 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.<br>|
| Active Comparator: Fed state<br> | Drug: Empagliflozin 10 mg Tab<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |