Bioequivalence Study of Dapagliflozin/Metformin Formulations 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. No secondary objectives are provided for this study.

The clinical trial involves **healthy volunteers** as the study population, encompassing both male and female participants. The age range of the participants is categorized as adults, specifically between 18 to 65 years. The trial population was selected to include individuals who are generally in good health, without any significant medical conditions. The sponsor has not provided information regarding the total number of participants. Participants' lifestyle considerations, such as diet, physical activity, or habits, are not specified. The trial does include a vulnerable population, although specific details about this group are not disclosed. Key inclusion or exclusion criteria have not been provided by the sponsor.

The clinical trial is designed to evaluate the **bioequivalence** of two formulations of dapagliflozin/metformin in **healthy volunteers**. This study is a Phase 2, randomized, double-blind, controlled trial. The estimated recruitment start date is September 1, 2025, with an anticipated end date of October 18, 2025. The trial will involve a series of study visits, beginning with an inclusion (screening) visit to assess eligibility based on predefined criteria. Participants who meet the inclusion criteria 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 potential adverse events. These visits will also involve the collection of pharmacokinetic data to assess the bioequivalence of the formulations. The end-of-study visit will occur after the final dose, where comprehensive assessments will be conducted to evaluate the primary and secondary endpoints of the trial. The expected length of participant involvement is approximately six weeks, from the screening visit to the end-of-study visit.

Participants may be withdrawn from the study if they experience significant adverse events, fail to comply with the study protocol, or withdraw consent. The trial is conducted in accordance with ethical guidelines and regulatory requirements to ensure the safety and well-being of all participants. The data collected will contribute to the understanding of the bioequivalence of the two formulations, potentially informing future clinical use.

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 2 study. The trial is scheduled to commence recruitment on September 1, 2025, with an estimated completion date of October 18, 2025. Efficacy will be evaluated using specific parameters or endpoints, although these are not detailed in the provided data. The methods and schedule for measuring, collecting, and analyzing these efficacy parameters are not specified. The trial will adhere to standard clinical trial protocols to ensure the reliability and validity of the efficacy assessments. The study will be conducted in accordance with regulatory requirements and ethical guidelines to ensure the integrity of the data collected.