Bioequivalence Study of Dapagliflozin 10 mg Tablets in Healthy Volunteers for Type 2 Diabetes, Chronic Heart Failure, and Chronic Kidney Disease

The primary objective of this study is to evaluate the **bioequivalence** of Dapagliflozin 10 mg film-coated tablets (Polfa Tarchomin S.A., Poland) compared to Froxiga 10 mg film-coated tablets (AstraZeneca AB, Sweden) in healthy volunteers under fasting conditions. This is clinically relevant as establishing bioequivalence ensures that the generic formulation is therapeutically equivalent to the branded product, which is crucial for the treatment of conditions such as insufficiently controlled **type 2 diabetes mellitus**, symptomatic chronic heart failure, and chronic kidney disease. No secondary objectives are provided in the available data.

The clinical trial involves participants with **insufficiently controlled type 2 diabetes mellitus**, symptomatic chronic heart failure, and chronic kidney disease. The study population includes both male and female subjects, with an age range categorized as 3, which typically corresponds to adults. The trial does not specifically target a vulnerable population. The sponsor has not provided information regarding the total number of participants or the selection process for the trial population. Participants are expected to have lifestyle considerations that include adherence to a diet and exercise regimen, as the trial is intended as an adjunct to these lifestyle modifications. Key inclusion or exclusion criteria have not been disclosed by the sponsor.

The clinical trial is designed as a **randomized**, open-label, two-period, two-sequence, crossover study to evaluate the bioequivalence of Dapagliflozin 10 mg film-coated tablets compared to Froxiga 10 mg film-coated tablets in healthy volunteers under fasting conditions. The trial is intended for the treatment of insufficiently controlled **type 2 diabetes mellitus** as an adjunct to diet and exercise, symptomatic chronic heart failure, and chronic kidney disease. The study is categorized as a Phase 2 trial, with an estimated recruitment start date of March 28, 2025, and an estimated end date of April 30, 2025.

Participants will undergo a sequence of study visits, beginning with an inclusion (screening) visit to assess eligibility based on predefined criteria. Following successful screening, participants will be randomized into one of two sequences for the crossover design. Each participant will receive a single dose of the investigational product in one period and the comparator product in the other period, with a washout period in between. The purpose of these visits is to monitor the pharmacokinetic parameters and ensure the safety and tolerability of the participants.

The expected length of participant involvement is approximately one month, including the screening, dosing, and follow-up phases. Follow-up visits will be conducted to collect necessary data and monitor any adverse events. The end-of-study visit will conclude the participant's involvement, ensuring all safety assessments are completed. Conditions that may lead to early termination from the study include the occurrence of significant adverse events, non-compliance with study procedures, or withdrawal of consent by the participant.

No specific information regarding the experimental medication, including its name, pharmaceutical form, dosage, route, and frequency of administration, is provided in the available data. Consequently, a detailed description of the experimental treatment cannot be formulated based on the current dataset.

Similarly, there is no information available about any non-experimental treatments, such as standard-of-care therapy, placebo, or comparator treatment, used in the study. Therefore, a description of these elements is not possible with the given data.

Additional relevant information about drug administration, dosing schedules, and participant compliance monitoring is also absent from the provided data. As such, no further details can be included in this description.

The clinical trial is in Phase 2 and is scheduled to have an estimated recruitment start date of March 28, 2025, with an estimated end date of April 30, 2025. The efficacy of the intervention will be assessed through specific parameters or endpoints, although these are not detailed in the provided data. The trial will follow a structured schedule for measuring, collecting, and analyzing these efficacy parameters, adhering to the standards expected in Phase 2 trials. The trial's design will ensure that efficacy assessments are conducted using scientifically validated methods and tools, although specific instruments are not mentioned. The trial will be conducted in accordance with regulatory requirements and scientific guidelines to ensure the reliability and validity of the efficacy data collected.