Open‑label, randomized, single‑dose, two‑period crossover bioavailability study of Empagliflozin/Metformin (12.5 mg/1000 mg) versus Synjardy in healthy volunteers.

The primary objective is to evaluate the comparative bioavailability of the test fixed‑combination tablet containing empagliflozin 12.5 mg and metformin 1000 mg versus the reference product Synjardy (empagliflozin 12.5 mg/metformin 1000 mg) in healthy adult volunteers under fasting conditions, by assessing key pharmacokinetic parameters such as peak plasma concentration and area under the concentration‑time curve.

The trial enrolled healthy volunteers of both sexes, including individuals classified as vulnerable, for the investigation of a therapy targeting diabetes. The sponsor did not provide the total number of participants, and the specific age range was not disclosed. Selection emphasized recruitment of individuals without known comorbidities, and participants were expected to maintain usual diet and physical activity patterns without additional restrictions. Inclusion required eligibility as a healthy adult volunteer; detailed exclusion criteria were not provided.

The study is a Phase 2, open‑label, crossover design in which healthy male and female volunteers receive a single oral dose of either Empagliflozin/Metformin fixed‑combination tablets (12.5 mg/1000 mg) or Synjardy tablets (12.5 mg/1000 mg) under fasting conditions, followed by a washout period and crossover to the alternate treatment. Participants undergo a screening visit to confirm eligibility, after which the first dosing visit is scheduled. Serial pharmacokinetic sampling occurs over a predefined interval post‑dose, and a follow‑up visit is performed to assess safety and tolerability before the washout period. After the washout, a second dosing visit replicates the sampling schedule for the alternate treatment, concluding with an end‑of‑study visit that includes final safety assessments and study completion procedures. Involvement of each participant spans approximately 4 weeks, encompassing screening, two dosing periods, and follow‑up visits. Early termination may occur if a participant experiences a serious adverse event, withdraws consent, fails to adhere to protocol requirements, or if intolerable side effects are observed.

Efficacy will be evaluated using predefined clinical endpoints appropriate for the treatment of diabetes as specified in the study protocol.