Evaluation of Pharmacokinetic Interaction Between Alogliptin and Empagliflozin in Healthy Subjects Under Fasting Conditions

The primary objective of this study is to evaluate the **drug-drug interaction** between Alogliptin 25 mg film-coated tablets and Empagliflozin 25 mg film-coated tablets in healthy participants under fasting conditions. Understanding the interaction between these two medications is clinically relevant as it may inform dosing recommendations and safety considerations when co-administering these drugs, which are commonly used in the management of type 2 diabetes mellitus. The study does not involve participants with any specific medical condition, as it focuses on healthy individuals to assess the pharmacokinetic interactions without the confounding effects of disease states.

The clinical trial involves a **study population** that includes both male and female participants, with an age range categorized as 3, which typically corresponds to adults. The trial population is noted to include a **vulnerable population**, although specific details regarding the nature of this vulnerability are not provided. The sponsor has not disclosed the total number of participants involved in the study. Participants do not have any specific medical conditions as a prerequisite for inclusion in the trial. Information regarding lifestyle considerations such as diet, physical activity, or habits has not been provided. The sponsor has not given detailed information on the selection criteria for the trial population.

The clinical trial is designed to evaluate the **drug-drug interaction** between Alogliptin 25 mg film-coated tablets and Empagliflozin 25 mg film-coated tablets in healthy participants under fasting conditions. This study is a Phase 3 trial, which is categorized as a randomized, double-blind, controlled trial. The estimated duration of the trial is from February 24, 2025, to April 4, 2025. Participants will be involved in the study for the entire duration unless early termination criteria are met.

The sequence of study visits begins with an inclusion visit, also known as the screening visit, where participants are assessed for eligibility based on predefined criteria. Following successful screening, participants will be randomized and will undergo a series of follow-up visits. These visits are scheduled to monitor the participants' health status, adherence to the study protocol, and to collect data on the interaction between the two drugs. The end-of-study visit marks the conclusion of the participant's involvement, where final assessments are conducted to ensure participant safety and to gather comprehensive data for analysis.

Participants are expected to remain in the study for its entire duration unless they meet conditions for early termination, such as adverse reactions, non-compliance with the study protocol, or withdrawal of consent. The trial is conducted under strict ethical guidelines to ensure the safety and well-being of all participants. The data collected will contribute to understanding the pharmacokinetic and pharmacodynamic interactions between the two medications in a healthy population.

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 commence recruitment on February 24, 2025, with an estimated completion date of April 4, 2025. The efficacy assessment will be conducted through a series of 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 is consistent and reliable. The study will adhere to rigorous standards typical of Phase 3 trials, focusing on evaluating the treatment's effectiveness in a larger population. The trial's design will likely include regular assessments at various timepoints to monitor progress and outcomes, although these specifics are not provided. The trial's objective is to gather comprehensive data to support the evaluation of the treatment's efficacy in the targeted medical condition.