A Bioequivalence Study of Empagliflozin 25 mg Film-Coated Tablets in Healthy Volunteers Under Fasting Conditions

The primary objective is to evaluate the bioequivalence of Empagliflozin 25 mg film-coated tablets compared to the reference product, Jardiance 25 mg film-coated tablets. This assessment is conducted in healthy volunteers under fasting conditions to determine if the test product exhibits comparable pharmacokinetics to the innovator medication.

The sponsor did not provide information regarding the total number of participants. The study population consists of healthy volunteers, including both males and females. The participants fall within age group 3. The study population is classified as including vulnerable individuals.

This is a bioequivalence study designed as a randomized, double-blind, controlled trial. The research compares Empagliflozin 25 mg film-coated tablets manufactured by VIANEX S.A. against the reference product Jardiance 25 mg film-coated tablets manufactured by Boehringer Ingelheim International GmbH. The investigation will be conducted in healthy volunteers under fasting conditions. The study sequence begins with a screening visit to determine eligibility. Subsequent follow-up visits will be conducted to monitor the subjects, concluding with an end-of-study visit. The estimated duration of the trial is from February 25, 2026, to April 1, 2026.

The assessment of efficacy in this Phase 2 clinical trial involves evaluating parameters in healthy volunteers. No specific endpoints, measurement methods, or tools were identified for the evaluation of efficacy.