Bioavailability Study of Telmisartan, Indapamide, and Amlodipine Interaction in Healthy Volunteers Under Fasting Conditions

The primary objective of this study is to evaluate the **bioavailability** and potential **drug-drug interaction** between **telmisartan**, **indapamide**, and **amlodipine** when co-administered, compared to the administration of each product alone. This is conducted in a randomized, single-dose, cross-over design under fasting conditions in healthy volunteers. Understanding these interactions is clinically relevant as it informs on the safety and efficacy of combined antihypertensive therapy, which is crucial for optimizing treatment regimens for patients with **high blood pressure**. No secondary objectives are specified for this study.

The clinical trial involves participants diagnosed with **high blood pressure**. The study population includes both male and female subjects, with an age range of 18 to 65 years. The trial does not focus on a vulnerable population. The sponsor has not provided information regarding the total number of participants. Participants were selected based on specific criteria, although these criteria have not been disclosed. Lifestyle considerations such as diet, physical activity, and habits have not been specified. The trial aims to gather data from a diverse group of adults to ensure comprehensive results.

The clinical trial is designed as a **randomized**, single-dose, cross-over bioavailability study to evaluate the **drug-drug interaction** between telmisartan tablets, indapamide tablets, and amlodipine tablets. The study will compare the co-administration of these drugs versus the administration of each product alone in three separate arms. The trial will be conducted under fasting conditions in healthy volunteers. The trial is categorized as a Phase 3 study and is expected to commence recruitment on June 10, 2024, with an estimated completion date of August 28, 2024.

Participants will undergo a sequence of study visits, beginning with an inclusion (screening) visit to assess eligibility based on predefined criteria. Following successful screening, participants will be randomized into one of the three study arms. Each participant will receive a single dose of the assigned treatment under fasting conditions, with subsequent cross-over to the other treatment arms as per the study protocol. Follow-up visits will be scheduled to monitor the participants' health status and collect necessary data for bioavailability analysis. The end-of-study visit will conclude the trial, where final assessments will be conducted to ensure participant safety and gather comprehensive data for analysis.

The expected length of participant involvement is approximately three months, encompassing the screening, treatment, and follow-up phases. Conditions that may lead to early termination from the study include adverse reactions to the study drugs, non-compliance with study procedures, or withdrawal of consent by the participant. The study aims to provide valuable insights into the pharmacokinetic interactions of these antihypertensive agents, contributing to the understanding of their combined use in managing **high blood pressure**.

The clinical trial documentation does not provide specific details regarding the experimental medication, including its name, pharmaceutical form, dosage, route, and frequency of administration. As such, 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. Consequently, no description of these elements can be included.

Additional relevant information about drug administration, dosing schedules, and participant compliance monitoring is also not provided in the source data. Therefore, no further details can be elaborated upon in this context.

The clinical trial is designed to assess the efficacy of the investigational treatment in a Phase 3 study. The trial is scheduled to commence recruitment on June 10, 2024, with an estimated completion date of August 28, 2024. The efficacy of the treatment will be evaluated through predefined primary and secondary endpoints, although specific endpoints are not detailed in the available data. The trial will follow a structured methodology to ensure the accurate collection and analysis of efficacy data, adhering to the standards expected in a Phase 3 clinical trial. The trial's design and execution will be aligned with regulatory requirements to ensure the reliability and validity of the efficacy assessments.