A Bioequivalence Study of Empagliflozin in Healthy Participants

The primary objective of this study is to establish the bioequivalence of empagliflozin. This evaluation is clinically relevant to ensure that the test formulation demonstrates comparable pharmacokinetics to the reference product, supporting the interchangeability of the medication. 8

The sponsor did not provide information regarding the total number of participants. The study population consists of healthy volunteers. The cohort includes both male and female subjects. The participants belong to an age group classified by the code 3. This trial is a bioequivalence study.

This bioequivalence study is designed as a controlled investigation to evaluate the pharmacological properties of empagliflozin. The research methodology involves a specific sequence of study visits, beginning with a screening visit to assess eligibility. Following successful screening, participants will undergo the necessary clinical procedures to complete the study requirements. The trial includes follow-up visits and concludes with an end-of-study visit. The total duration of participant involvement is determined by the clinical protocol, and early termination may occur if specific predefined criteria are met. The estimated period for recruitment is expected to conclude by April 2026.

The efficacy assessment for this bioequivalence study involves comparing the pharmacokinetic profiles of the test and reference products in healthy participants.