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

The primary objective of this study is to evaluate the **drug-drug interaction** between Empagliflozin 25 mg film-coated tablets and Alogliptin 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 in clinical practice. No secondary objectives are specified for this study.

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 Empagliflozin 25 mg film-coated tablets and Alogliptin 25 mg film-coated tablets in healthy participants under fasting conditions. This study is a Phase 3 trial, which is randomized, double-blind, and controlled to ensure the reliability and validity of the results. The trial is expected to commence on February 17, 2025, with an estimated completion date of March 30, 2025, indicating a total duration of approximately six weeks.

Participants will undergo a series of study visits, beginning with an inclusion visit, also known as the screening visit, to assess eligibility based on predefined criteria. Following successful screening, participants will be randomized into different study arms. Throughout the trial, there will be scheduled follow-up visits to monitor the participants' health status and collect necessary data. The end-of-study visit will conclude the trial, where final assessments will be conducted to evaluate the primary and secondary endpoints.

The expected length of participant involvement is approximately six weeks, aligning with the overall trial duration. Conditions that may lead to early termination from the study include adverse reactions to the investigational products, non-compliance with study protocols, or withdrawal of consent by the participant. The trial is conducted under strict ethical guidelines to ensure participant safety and data integrity.

The clinical trial documentation does not provide specific details regarding the **experimental medication** used in the study. Information such as the name, pharmaceutical form, dosage, route, and frequency of administration is not available. Additionally, there is no data on whether the medication is a **paediatric formulation** or if it is classified as an **orphan drug**. The maximum daily dose, total dose, and treatment period are also unspecified.

Details about any **non-experimental treatments** used in the study, such as standard-of-care therapy, placebo, or comparator treatment, are not provided. There is no information on the administration of other medicinal products or their role in the trial.

Due to the lack of available data, no additional relevant information about drug administration, dosing schedules, or participant compliance monitoring can be described. The trial documentation does not include any product authorization status or details about the product's pharmaceutical form or active substances.

The clinical trial is designed to assess efficacy in a Phase 3 study. The trial is scheduled to begin recruitment on February 17, 2025, with an estimated end date of March 30, 2025. 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 is consistent and reliable. The trial's design and execution will adhere to the standards expected in a Phase 3 clinical trial, focusing on the rigorous evaluation of the investigational product's effectiveness.