Bioequivalence Study of Nitrofuranoin 100 mg Prolonged-Release Capsules in Healthy Subjects Under Fed Conditions

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 a fed state. This is clinically relevant as establishing bioequivalence ensures that the two formulations can be used interchangeably, providing flexibility in treatment options for patients requiring nitrofurantoin therapy. The study is conducted in healthy subjects to assess the pharmacokinetic parameters without the influence of disease-related factors.

The clinical trial involves **healthy subjects** of both genders, with an age range of 18 to 65 years. 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, throughout the study. The sponsor did not specify any 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 NITROFURANTOIN 100 mg prolonged-release capsules compared to FURABID® 100 mg prolonged-release capsules. The study will involve **healthy subjects** and is categorized as a Phase 2 trial. The trial is expected to commence recruitment on September 1, 2023, and conclude by October 31, 2023. Participants will be involved in a crossover replicate design, which allows each subject to receive both the test and reference formulations in a fed state, ensuring a comprehensive comparison of the pharmacokinetic profiles.

The sequence of study visits includes an initial **screening visit** to assess eligibility based on inclusion and exclusion criteria, although specific criteria are not detailed in the available data. Following successful screening, participants will be randomized to receive either the test or reference product in the first period, followed by a washout period, and then crossover to the alternate product in the subsequent period. The study will include follow-up visits to monitor safety and collect pharmacokinetic data at specified intervals. The **end-of-study visit** will occur after the final dosing period to ensure participant safety and collect any remaining data.

The expected length of participant involvement is approximately two months, considering the recruitment, treatment, and follow-up phases. 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 aims to ensure the safety and well-being of participants while providing robust data on the bioequivalence of the two formulations under investigation.

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 the administration, dosing schedules, or participant compliance monitoring for these treatments.

Due to the lack of available data, further specifics regarding the **experimental medication** and any **non-experimental treatments** cannot be described. The absence of this information limits the ability to provide a comprehensive overview of the treatments involved in the clinical trial.

The clinical trial is designed to assess efficacy in a Phase 2 study. The trial is scheduled to begin recruitment on September 1, 2023, and is estimated to conclude by October 31, 2023. The efficacy assessment will be conducted using 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. The study will adhere to rigorous clinical standards to evaluate the therapeutic impact of the intervention under investigation. The trial's design and execution will be aligned with the objectives of a Phase 2 study, focusing on efficacy and safety within the specified timeframe.