Bioequivalence Study of Edoxaban 60 mg Tablets Versus Film-Coated Tablets in Healthy Volunteers Under Fasting Conditions

The primary objective of this study is to evaluate the **bioequivalence** of edoxaban 60 mg tablets compared to edoxaban 60 mg film-coated tablets. This is assessed after a single oral dose administration to healthy volunteers under fasting conditions. Establishing bioequivalence is clinically relevant as it ensures that the two formulations of edoxaban provide the same therapeutic effect and safety profile, which is crucial for maintaining consistent patient outcomes and treatment efficacy.

The clinical trial involves **healthy volunteers** as the study population, encompassing both male and female participants. The age range of the participants is categorized as adults, although specific age details are not provided. The trial does not focus on a vulnerable population. The sponsor has not disclosed the total number of participants involved in the study. Selection criteria for the trial population, including any lifestyle considerations such as diet or physical activity, have not been specified. The sponsor has not provided detailed information regarding key inclusion or exclusion criteria for this trial.

The clinical trial is designed as a **randomized**, crossover bioequivalence study to evaluate the pharmacokinetic properties of edoxaban 60 mg tablets compared to edoxaban 60 mg film-coated tablets. The trial will involve healthy volunteers and will be conducted under fasting conditions. The study is classified as a Phase 2 trial, with an estimated recruitment start date of June 9, 2025, and an estimated end date of July 18, 2025. The trial will employ a double-blind, controlled methodology to ensure unbiased results.

Participants will undergo a series of study visits, beginning with an inclusion visit, also known as the screening visit, to assess eligibility based on predefined criteria. Following successful screening, participants will be randomized to receive either the tablet or film-coated formulation of edoxaban. The crossover design will allow each participant to receive both formulations in a sequential manner, with a washout period between administrations to prevent carryover effects. Follow-up visits will be scheduled to monitor the participants' health status and collect pharmacokinetic data at specified intervals. The end-of-study visit will conclude the trial, during which final assessments will be conducted to ensure participant safety and gather any remaining data.

The expected length of participant involvement in the trial is approximately six weeks, accounting for the screening, 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 trial aims to provide robust data on the bioequivalence of the two formulations of edoxaban, contributing to the understanding of their pharmacokinetic profiles in healthy individuals.

No specific information regarding the experimental medication, including its name, pharmaceutical form, dosage, route, and frequency of administration, is available from the provided data. Consequently, a detailed description of the experimental treatment cannot be provided.

Similarly, there is no information available about any non-experimental treatments, such as standard-of-care therapy, placebo, or comparator treatment, used in the study. Therefore, a description of these elements is not possible based on the current data.

Additional relevant information about drug administration, dosing schedules, and participant compliance monitoring is also not provided in the source data. As such, no further details can be included in this description.

The clinical trial is designed to assess efficacy in a Phase 2 study. The trial is scheduled to begin recruitment on June 9, 2025, with an estimated end date of July 18, 2025. The specific parameters or endpoints used to evaluate efficacy, as well as the methods and schedule for measuring, collecting, and analyzing these parameters, are not provided in the available data. The trial's focus is on determining the efficacy of the intervention within the specified timeframe, adhering to the standards and protocols typical of Phase 2 clinical trials. The trial will proceed according to the established timeline, ensuring that all assessments are conducted systematically and in accordance with regulatory requirements.