A Bioequivalence Study of Two Formulations of Dapagliflozin and Metformin in Healthy Volunteers

The primary objective of this study is to evaluate the **bioequivalence** of two formulations of dapagliflozin/metformin in healthy volunteers. Bioequivalence studies are crucial in determining whether different formulations of a drug release the active ingredient into the bloodstream at the same rate and extent, ensuring therapeutic equivalence. This is clinically relevant as it ensures that patients receive the same therapeutic benefits and safety profile from different formulations of the same medication.

The clinical trial involves **healthy volunteers** as the study population, with both male and female participants included. The age range of participants is categorized as adults, although specific age details are not provided. The trial population selection criteria and the total number of participants are not disclosed by the sponsor. Participants are expected to be in good general health, as indicated by their classification as healthy volunteers. The study does not specify any particular lifestyle considerations such as diet, physical activity, or habits. The trial includes a vulnerable population, but further details on this aspect are not provided. Key inclusion or exclusion criteria are not available from the sponsor's information.

The clinical trial is designed to evaluate the **bioequivalence** of two formulations of dapagliflozin/metformin in **healthy volunteers**. This study is structured as a Phase 2, randomized, double-blind, controlled trial. The estimated recruitment start date is May 15, 2025, with an anticipated end date of July 1, 2025. The trial will involve a series of study visits, beginning with an inclusion visit, where participants will undergo screening to confirm eligibility based on predefined criteria. Following successful screening, participants will be randomly assigned to receive one of the two formulations under investigation.

Throughout the trial, participants will attend scheduled follow-up visits to monitor safety, adherence, and any adverse events. These visits are crucial for collecting data on the pharmacokinetic parameters of the formulations. The end-of-study visit will mark the conclusion of the participant's involvement, during which final assessments will be conducted to ensure participant safety and gather comprehensive data for analysis. The expected duration of participant involvement is approximately six weeks, contingent upon adherence to the study protocol.

Participants may be subject to early termination from the study if they experience significant adverse events, fail to comply with the study protocol, or withdraw consent. The trial's methodology ensures rigorous data collection and analysis, maintaining the integrity and reliability of the results. The study's design and procedures are aligned with ethical standards and regulatory requirements, ensuring the safety and well-being of all participants throughout the trial duration.

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

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

Additional relevant information about drug administration, dosing schedules, and participant compliance monitoring is also not provided in the source data. As such, these aspects cannot be detailed in this description.

The clinical trial is designed to assess efficacy through a structured evaluation process. The trial is categorized as a Phase 2 study, which typically focuses on assessing the efficacy of a treatment, as well as its side effects. The trial is scheduled to commence recruitment on May 15, 2025, with an estimated end date of July 1, 2025. Although specific efficacy parameters such as primary and secondary endpoints are not detailed, Phase 2 trials generally involve the use of validated scales, laboratory tests, or patient-reported outcomes to measure treatment effects. The data collection and analysis will be conducted according to the standard protocols for Phase 2 trials, ensuring rigorous assessment of the treatment's impact on the targeted medical condition. The trial will adhere to established methodologies to ensure the reliability and validity of the efficacy assessments.