Comparative Bioavailability Study of Dapagliflozin/Metformin Hydrochloride 5 mg/1000 mg Versus Reference Product in Healthy Adults Under Fed Conditions

The primary objective of this study is to evaluate the **bioavailability** of a test product, Dapagliflozin/metformin hydrochloride 5 mg/1000 mg film-coated tablets, in comparison to the reference product, Xigduo 5 mg/1000 mg film-coated tablets. This assessment is conducted in healthy adult male and female subjects under fed conditions. Understanding the bioavailability of these formulations is clinically relevant as it informs on the absorption and systemic availability of the active ingredients, which is crucial for determining the therapeutic efficacy and safety of the medication.

The clinical trial involves a **bioavailability study** conducted in **healthy volunteers** under fed conditions. The study population includes both male and female participants, with an age range categorized as 18 to 65 years. The trial does not specify the total number of participants, as the sponsor has not provided this information. Participants were selected based on their general health status, ensuring they are free from significant medical conditions that could interfere with the study outcomes. The trial population includes individuals who are not part of any vulnerable groups. Lifestyle considerations such as diet and physical activity are relevant, as the study is conducted under fed conditions, but specific details are not provided. Key inclusion or exclusion criteria have not been disclosed by the sponsor.

The clinical trial is designed as a **randomized**, open-label, laboratory-blinded, 2-treatment, 2-period, 2-sequence crossover study. It aims to assess the comparative **bioavailability** of a test product, Dapagliflozin/metformin hydrochloride 5 mg/1000 mg film-coated tablets, against a reference product, Xigduo 5 mg/1000 mg film-coated tablets, in healthy adult male and female subjects under fed conditions. The trial is categorized as a Phase 3 study and is expected to commence recruitment on September 29, 2025, with an estimated completion date of October 22, 2025.

Participants will undergo a series of study visits, beginning with an inclusion (screening) visit to determine eligibility based on predefined criteria. Following successful screening, participants will be randomized into one of the two treatment sequences. Each treatment period will involve the administration of a single dose of either the test or reference product, with a washout period between the two treatment phases to ensure no carryover effects. The study will include follow-up visits to monitor safety and collect pharmacokinetic data. The end-of-study visit will conclude the participant's involvement, during which final assessments will be conducted to ensure participant safety and gather any remaining data.

The expected length of participant involvement is approximately one month, encompassing the screening, treatment, and follow-up phases. Conditions that may lead to early termination from the study include adverse events, non-compliance with study procedures, or withdrawal of consent by the participant. The study is conducted under controlled conditions to ensure the integrity of the data collected and the safety of the participants.

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 designed to assess efficacy in a Phase 3 study. The trial is scheduled to begin recruitment on September 29, 2025, with an estimated end date of October 22, 2025. The efficacy assessment will be conducted using predefined primary and secondary endpoints, although specific endpoints are not detailed in the available data. The trial will follow a structured methodology to ensure the accurate collection and analysis of efficacy data. The trial's design and execution will adhere to rigorous standards to ensure the reliability and validity of the results.