Bioequivalence Study of Furosemide 500 mg Tablets Versus Lasix 500 mg Tablets in Healthy Male Volunteers Under Fasting Conditions

The primary objective of this study is to assess the **bioequivalence** between Furosemide 500 mg tablets (Test) and Lasix 500 mg tablets (Reference) in healthy male volunteers under fasting conditions. Bioequivalence studies are crucial in determining whether the test product releases its active ingredient into the bloodstream at the same rate and extent as the reference product. This is clinically relevant as it ensures that the test product can be used interchangeably with the reference product, maintaining therapeutic efficacy and safety.

The clinical trial involves **healthy volunteers** with a focus on male participants. The study population is comprised of individuals within the age range of 18 to 65 years. The trial does not include a vulnerable population, and the selection process for participants has not been disclosed by the sponsor. The study does not specify any particular lifestyle considerations such as diet, physical activity, or habits. The sponsor has not provided information regarding the total number of participants involved in the trial. The trial is designed to assess healthy individuals, and no specific medical conditions are being targeted.

The clinical trial is designed as an **open-label**, four-period, two-sequence, fully replicated, randomized, single-dose pivotal study. The primary aim is to assess the **bioequivalence** between Furosemide 500 mg tablets (Test) and Lasix 500 mg tablets (Reference) in healthy male volunteers under fasting conditions. The trial is categorized as a Phase 2 study and is expected to commence recruitment on September 15, 2023, with an estimated completion date of November 30, 2023. The study will involve healthy volunteers, and no specific medical condition is being targeted.

Participants will undergo a sequence of study visits, beginning with an inclusion (screening) visit to determine eligibility based on predefined criteria. Following successful screening, participants will be randomized into one of the two sequences. Each participant will receive a single dose of the test and reference products across four periods, with adequate washout intervals between doses to prevent carryover effects. The study will include follow-up visits to monitor safety and collect pharmacokinetic data. The end-of-study visit will conclude the participant's involvement, ensuring all necessary data is collected and any adverse events are addressed.

The expected length of participant involvement is approximately two and a half months, from the initial screening to the end-of-study visit. Conditions that may lead to early termination from the study include non-compliance with study procedures, adverse events that compromise participant safety, or withdrawal of consent. The study is conducted under fasting conditions to ensure consistent and reliable data collection, adhering to rigorous scientific standards to evaluate the bioequivalence of the test and reference products.

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.

Due to the lack of specific data, additional relevant information about drug administration, dosing schedules, and participant compliance monitoring cannot be detailed. The absence of this information precludes the provision of a comprehensive description of the treatments used in this clinical trial.

The clinical trial is designed to assess efficacy in a Phase 2 study. The trial is scheduled to begin recruitment on September 15, 2023, with an estimated end date of November 30, 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. The methods and tools for measuring efficacy, as well as the specific timepoints for these assessments, are not specified in the provided information. The trial's focus is on evaluating the efficacy of the intervention within the defined trial phase and category.