Pharmacokinetic Evaluation of Rifaximin Soluble Solid Dispersion in Adults with Hepatic Impairment

The primary objective of this study is to assess the **pharmacokinetics** of the Rifaximin Soluble Solid Dispersion (SSD) formulation in adult subjects with **hepatic impairment**. Understanding the pharmacokinetics in this population is clinically relevant as it provides insights into the drug's absorption, distribution, metabolism, and excretion, which are crucial for optimizing dosing regimens and ensuring safety and efficacy in patients with compromised liver function.

The clinical trial involves a total of **14 participants** diagnosed with **hepatic impairment**. The study population includes both male and female subjects, with an age range that corresponds to categories 3 and 4, indicating a broad spectrum of adult ages. Participants were selected to include a vulnerable population, although specific inclusion or exclusion criteria were not provided by the sponsor. The trial does not specify any particular lifestyle considerations such as diet, physical activity, or habits. The selection process aimed to encompass a diverse group of individuals to ensure comprehensive data collection relevant to the study's focus on hepatic impairment.

The clinical trial is designed to evaluate the **pharmacokinetics** of a Rifaximin Soluble Solid Dispersion (SSD) formulation in adult subjects with **hepatic impairment**. This study is a Phase 3 trial, which is categorized as a randomized, double-blind, and controlled trial. The estimated recruitment start date is September 16, 2023, with an anticipated end date of March 31, 2024. The trial will involve a series of study visits, beginning with an inclusion (screening) visit to assess eligibility based on specific criteria. Participants will then undergo a series of follow-up visits to monitor their response to the treatment and to collect necessary data. The end-of-study visit will conclude the trial, where final assessments will be conducted to evaluate the outcomes.

Participants are expected to be involved in the study for the entire duration, from the initial screening to the end-of-study visit, unless specific conditions necessitate early termination. Such conditions may include adverse reactions, non-compliance with study protocols, or withdrawal of consent. The trial aims to ensure the safety and well-being of participants while gathering comprehensive data on the pharmacokinetics of the investigational product. The study's design and procedures are structured to maintain scientific rigor and integrity, ensuring that the results are reliable and applicable to the target population.

The clinical trial documentation does not provide specific details regarding the experimental medication, including its name, pharmaceutical form, dosage, route, or 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 treatments 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 in Phase 3 and is scheduled to have an estimated recruitment start date of September 16, 2023, with an estimated end date of March 31, 2024. The efficacy of the investigational treatment will be assessed 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 timeline to ensure systematic data collection and analysis, adhering to the rigorous standards expected in Phase 3 trials. The focus will be on evaluating the treatment's impact on the disease, with assessments likely to be conducted at various timepoints throughout the trial duration. The trial's design will ensure that efficacy assessments are conducted using scientifically validated methods, although specific tools or instruments are not mentioned in the provided information.