Bioequivalence Study of Linagliptin/Metformin 2.5 mg/1000 mg Tablets in Healthy Volunteers Under Fed Conditions

The primary objective of this study is to evaluate the **bioequivalence** of linagliptin/metformin 2.5 mg/1000 mg film-coated tablets following a single oral dose administration in healthy volunteers under fed conditions. This is clinically relevant as establishing bioequivalence ensures that the generic formulation of the medication is therapeutically equivalent to the brand-name counterpart, which is crucial for maintaining consistent efficacy and safety in the management of **diabetes**. No secondary objectives are provided in the available data.

The clinical trial involves participants diagnosed with **diabetes**. The study population includes both male and female subjects, with an age range category code of 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. Selection criteria and lifestyle considerations such as diet, physical activity, or habits have not been detailed in the available data. The sponsor has not disclosed key inclusion or exclusion criteria for this study.

The clinical trial is designed as a **randomized**, crossover bioequivalence study to evaluate the pharmacokinetic properties of linagliptin/metformin 2.5 mg/1000 mg film-coated tablets. The trial will be conducted under fed conditions in healthy volunteers. The study is structured to ensure that each participant receives both the test and reference formulations in a crossover manner, allowing for direct comparison within the same individual. The trial is set to commence on May 1, 2024, with an estimated completion date of May 31, 2024, indicating a total duration of approximately one month.

Participants will undergo a series of study visits, beginning with an inclusion visit, which serves as a screening to assess eligibility based on predefined criteria. This visit will include obtaining informed consent, medical history review, and baseline assessments. Following the inclusion visit, participants will be randomized to receive either the test or reference formulation, with subsequent crossover to the alternate formulation after a washout period. Follow-up visits will be scheduled to monitor safety, collect pharmacokinetic samples, and assess any adverse events. The end-of-study visit will involve final safety assessments and the collection of any remaining data.

The expected length of participant involvement is approximately one month, encompassing all study visits and procedures. 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. The trial is conducted in accordance with ethical guidelines and regulatory requirements, ensuring the safety and well-being of all participants throughout the study duration.

The clinical trial documentation does not provide specific details regarding the experimental medication, including its name, pharmaceutical form, dosage, route, or frequency of administration. Consequently, no detailed description of the experimental treatment can be provided based on the available data.

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. As such, no description of these elements can be included.

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

The clinical trial is designed to assess efficacy in a Phase 2 study. The trial is scheduled to commence recruitment on May 1, 2024, with an estimated completion date of May 31, 2024. The efficacy assessment will be conducted using predefined parameters, although specific endpoints and methods for measuring efficacy are not detailed in the available data. The trial will follow a structured protocol to ensure the collection and analysis of efficacy data, adhering to the standards expected in clinical research. The trial's focus is on evaluating the therapeutic impact of the intervention, with the aim of determining its potential benefits in the targeted medical condition. The study will be conducted in accordance with regulatory guidelines to ensure the reliability and validity of the efficacy outcomes.