Bioequivalence Study of Nitrofuranoin 100 mg Prolonged-Release Capsules in Healthy Subjects: A Crossover Replicate Design

The primary objective of this study is to evaluate the **bioequivalence** of NITROFURANTOIN 100 mg prolonged-release capsules (IASIS PHARMA) compared to FURABID® 100 mg prolonged-release capsules (Amdipharm Limited) in healthy subjects. 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 patient safety. This study is conducted in a fasted state using a single-dose, crossover replicate design to provide robust data on the pharmacokinetic profiles of the two formulations.

The clinical trial involves **healthy subjects** with an age range of 18 to 65 years, encompassing both male and female participants. The sponsor did not provide information regarding the total number of participants. The trial population was selected to include individuals who are not part of a vulnerable population. Participants are expected to maintain their usual lifestyle, including diet and physical activity, as no specific lifestyle modifications are required for this study. The selection criteria focus on ensuring the inclusion of healthy individuals, although specific inclusion or exclusion criteria were not detailed by the sponsor.

The clinical trial is designed as a **randomized**, **double-blind**, **controlled** study to evaluate the bioequivalence of two formulations of nitrofurantoin 100 mg prolonged-release capsules. The trial will involve **healthy subjects** and is categorized as a Phase 2 study. The estimated recruitment start date is January 1, 2025, with an anticipated end date of May 1, 2025. The trial will follow a crossover replicate design, allowing each participant to receive both the test and reference formulations in a randomized sequence, ensuring robust comparison of pharmacokinetic parameters.

Participants will undergo a series of study visits, beginning with an inclusion (screening) visit to assess eligibility based on predefined criteria. This visit will include a comprehensive medical evaluation and laboratory tests to confirm the health status of the subjects. Following successful screening, participants will be randomized to receive either the test or reference formulation in the first treatment period. Subsequent visits will include follow-up assessments to monitor safety and collect pharmacokinetic data. The crossover design will necessitate a washout period between treatment phases to prevent carryover effects. The end-of-study visit will occur after the final treatment period, where a thorough evaluation will be conducted to ensure participant safety and collect final data.

The expected length of participant involvement is approximately four months, encompassing all study visits and treatment periods. Conditions that may lead to early termination from the study include adverse events, non-compliance with study procedures, or withdrawal of consent by the participant. The study is structured to maintain the highest ethical standards and ensure the safety and well-being of all participants throughout the trial duration.

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 additional relevant aspects of drug administration, dosing schedules, or participant compliance monitoring. The absence of these details limits the ability to describe the treatment protocols accurately.

The clinical trial is designed to assess efficacy in a Phase 2 study. The trial is scheduled to commence recruitment on January 1, 2025, with an estimated completion date of May 1, 2025. The efficacy assessment will be conducted through a series of pre-defined parameters, although specific endpoints and methods for measuring efficacy are not detailed in the provided data. The trial will follow a structured timeline to ensure systematic data collection and analysis. The focus will be on evaluating the therapeutic impact of the intervention, with results contributing to the understanding of its potential benefits in the targeted medical condition. The trial will adhere to rigorous standards to ensure the reliability and validity of the efficacy outcomes.