Pharmacokinetics and Bioequivalence of Two Empagliflozin, With Evaluation in Healthy Jordanian Subjects Under Fasting and Fed Conditions
- Sponsor
- Mutah University
- Study ID
- NCT05229796
- Status
- Completed
Conditions
- Pharmacokinetic Parameters
Eligibility Criteria
- Sex
- ALL
- Age
- 25 Years - 40 Years
- Healthy Volunteers
- Accepted
Interventions
- Empagliflozin 10 mg Tab — DRUGThe 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.
Study Details
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.
Key Dates
- Start date
- May 17, 2021
- Status verified
- Jan 2022
- Primary completion
- Dec 10, 2021
- Completion
- Dec 12, 2021
Study Design
- Enrollment
- 26 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- CROSSOVER
- Primary purpose
- BASIC_SCIENCE
Arms
- Active Comparator: Fasting state
- Active Comparator: Fed state
Primary Outcome Measure
The plasma concentrations of empagliflozin were determined using an HPLC-MS/MS method. [ Time Frame: 5 months ]