Pharmacokinetics and Safety Evaluation of Rupatadine and Metabolites in Renal Impairment and Normal Renal Function in Allergic Rhinitis and Urticaria Patients

The primary objective of this study is to evaluate the **pharmacokinetics** and safety profile of rupatadine (10 mg) and its active metabolites in participants with renal impairment compared to matched control participants with normal renal function. This investigation is clinically relevant as it aims to understand how renal impairment affects the metabolism and safety of rupatadine, a medication used in the treatment of **allergic rhinitis** and **urticaria**. Understanding these effects is crucial for optimizing dosing regimens and ensuring safe use in patients with compromised renal function.

The clinical trial involves participants diagnosed with **allergic rhinitis** and **urticaria**. The study population includes both male and female subjects, with an age range that encompasses both children and adults. The trial specifically includes vulnerable populations, although the exact criteria for vulnerability are not detailed. The total number of participants is not provided, as the sponsor has not disclosed this information. Participants were selected based on unspecified criteria, and no specific lifestyle considerations such as diet or physical activity are mentioned. The trial does not specify any principal inclusion or exclusion criteria, and the main objective of the trial is not detailed in the available data.

The clinical trial is designed to evaluate the **pharmacokinetics** and safety of rupatadine (10 mg) and its active metabolites in participants with renal impairment compared to matched control participants with normal renal function. This study is a Phase 3, randomized, double-blind, controlled trial. The estimated recruitment start date was September 1, 2022, with an anticipated end date of January 31, 2023. The trial involves participants diagnosed with **allergic rhinitis** or **urticaria**. The sequence of study visits includes an initial screening visit to assess eligibility based on inclusion and exclusion criteria, followed by multiple follow-up visits to monitor the participants' response to the treatment and any adverse effects. 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 five months, from the initial screening to the end-of-study visit. Conditions that may lead to early termination from the study include significant adverse reactions, non-compliance with study protocols, or withdrawal of consent by the participant. The trial aims to provide comprehensive data on the safety and efficacy of rupatadine in the specified population, contributing to the understanding of its use in individuals with varying renal function.

The clinical trial involves the administration of an **experimental medication**. However, specific details regarding the name, pharmaceutical form, dosage, route, and frequency of administration of the experimental medication are not provided in the available data. The trial documentation does not specify whether the medication is a **paediatric formulation** or if it is classified as an **orphan drug**. Additionally, there is no information on the maximum daily dose, total dose, or treatment period for the experimental medication.

In this clinical trial, there is no mention of any **non-experimental treatments** such as standard-of-care therapy, placebo, or comparator treatment being used. The data does not provide details on any additional relevant information about drug administration, dosing schedules, or participant compliance monitoring. The absence of these details suggests that the trial may focus solely on the experimental medication without a comparator or placebo group.

The clinical trial is designed to assess efficacy in a Phase 3 study. The trial is scheduled to begin recruitment on September 1, 2022, and is estimated to conclude by January 31, 2023. The efficacy assessment will be conducted through a series of planned evaluations, although specific parameters or endpoints for efficacy evaluation are not detailed in the available data. The trial will follow a structured timeline to ensure systematic data collection and analysis, adhering to the rigorous standards expected in a Phase 3 clinical trial. The trial's design and execution will focus on generating reliable and valid data to support the efficacy claims of the investigational product. The absence of specific endpoints or measurement tools in the provided data suggests that these details will be defined in the full trial protocol, ensuring comprehensive assessment and analysis of the trial outcomes.