Pharmacokinetic Parameters
Conditions
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.
Interventions
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
Mutah University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
25 Years to 40 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The plasma concentrations of empagliflozin were determined using an HPLC-MS/MS method. | 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. |
Countries
Jordan
Outcome results
None listed