Bioequivalence Study of Rifaximin 200 mg Film-Coated Tablets in Healthy Subjects Under Fasting Conditions

The primary objective of this study is to evaluate the **bioequivalence** of Rifaximin 200 mg film-coated tablets (Antibiotice S.A.) compared to Normix® 200 mg film-coated tablets (Alfasigma S.p.A) in healthy subjects under fasting conditions. Bioequivalence studies are crucial in determining whether two pharmaceutical products are equivalent in their rate and extent of absorption, which is essential for ensuring therapeutic equivalence and safety in clinical practice.

The clinical trial involves **healthy subjects** of both genders, with an age range corresponding to category code 3, which typically includes adults. The study population is not part of a vulnerable group, and the selection process for participants has not been detailed by the sponsor. The total number of participants has not been provided. No specific lifestyle considerations such as diet, physical activity, or habits have been mentioned. The sponsor has not disclosed key inclusion or exclusion criteria for this trial.

The clinical trial is designed as a **randomized**, **double-blind**, controlled study to evaluate the bioequivalence of Rifaximin 200 mg film-coated tablets compared to Normix® 200 mg film-coated tablets. The trial will involve **healthy subjects** and is categorized as a Phase 2 study. The estimated recruitment start date is May 6, 2024, with an anticipated end date of November 30, 2024. The trial will be conducted in two stages under fasting conditions to ensure the accurate assessment of bioequivalence between the two formulations.

Participants will undergo a series of study visits, beginning with an inclusion visit, also known as the screening visit, to determine eligibility based on predefined criteria. This visit will involve a comprehensive assessment of the participant's health status to confirm their suitability for the trial. Following successful screening, participants will be randomized to receive either the test or reference product in a crossover manner, ensuring each participant receives both treatments at different times. The sequence of study visits will include baseline assessments, dosing visits, and follow-up visits to monitor safety and collect pharmacokinetic data.

The expected length of participant involvement in the trial is approximately six months, encompassing all study visits and assessments. Participants may be subject to early termination from the study if they experience adverse events that compromise their safety, fail to comply with study procedures, or withdraw consent. The end-of-study visit will mark the conclusion of the participant's involvement, during which final assessments will be conducted to ensure participant safety and collect any remaining data. The trial's design and procedures are structured to maintain scientific rigor and ensure the reliability of the study outcomes.

In this clinical trial, the experimental medication and non-experimental treatments have not been specified in the provided data. Therefore, a detailed description of the **experimental medication**, including its name, pharmaceutical form, dosage, route, and frequency of administration, cannot be provided. Similarly, information regarding any non-experimental treatments, such as standard-of-care therapy, placebo, or comparator treatment, is not available. Consequently, additional relevant information about drug administration, dosing schedules, and participant compliance monitoring is also not included. The absence of this data precludes a comprehensive description of the treatments used in the study.

The clinical trial is designed to assess efficacy through a structured evaluation process. The trial is categorized as a Phase 2 study, indicating its focus on evaluating the efficacy and side effects of the intervention. The estimated recruitment start date is May 6, 2024, with an anticipated end date of November 30, 2024. The trial will employ scientifically validated methods to measure and analyze efficacy parameters, although specific endpoints and measurement tools are not detailed in the available data. The study will adhere to rigorous standards to ensure the reliability and validity of the efficacy assessments conducted throughout the trial duration.