Pharmacokinetics and Bioequivalence of Two Empagliflozin, With Evaluation in Healthy Jordanian Subjects Under Fasting and Fed Conditions
- Conditions
- Pharmacokinetic Parameters
- Interventions
- Registration Number
- NCT05229796
- Lead Sponsor
- Mutah University
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 26
Inclusion Criteria:
- healthy
- Jordanian volunteers
- some private hospitals (Amman, Jordan) Phase I Clinical Unit
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Fed state Empagliflozin 10 mg Tab - Fasting state Empagliflozin 10 mg Tab -
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Wael Abu Dayyih
🇯🇴Amman, None Selected, Jordan