Bioequivalence Study of Rivaroxaban and Acetylsalicylic Acid Formulations in Healthy Volunteers Under Fasting Conditions for Increased Blood Clotting

The primary objective of this study is to evaluate the **bioequivalence** of two formulations containing **rivaroxaban** and **acetylsalicylic acid** in healthy volunteers under fasting conditions. This is clinically relevant as it assesses whether the two formulations can be used interchangeably without compromising therapeutic efficacy or safety in managing conditions associated with **increased blood clotting**. The study employs a single-dose, randomized, two-period, two-sequence, crossover design to achieve this objective.

The clinical trial focuses on participants with **increased blood clotting**. The study population includes both male and female subjects, with an age range that corresponds to category code 3, which typically includes adults. The trial involves a vulnerable population, although specific details regarding the vulnerability are not provided. The sponsor has not disclosed the total number of participants involved in the study. Selection criteria and lifestyle considerations such as diet, physical activity, or habits have not been specified. The absence of detailed inclusion or exclusion criteria suggests that the trial may have broad eligibility requirements, but this cannot be confirmed without additional information from the sponsor.

The clinical trial is designed as a **randomized**, two-period, two-sequence, crossover pilot study to evaluate the **bioequivalence** of formulations containing **rivaroxaban** and **acetylsalicylic acid** in healthy volunteers under fasting conditions. The trial is conducted to address the medical condition of **increased blood clotting**. The study is categorized as a Phase 2 trial, with an estimated recruitment start date of February 1, 2024, and an anticipated end date of March 30, 2024. The trial involves a sequence of study visits, beginning with an inclusion visit where participants are screened for eligibility based on predefined criteria. This is followed by two treatment periods where participants receive the investigational products in a randomized order, with a washout period in between to ensure no carryover effects. Each treatment period includes a series of follow-up visits to monitor the participants' health and collect necessary data. The end-of-study visit marks the conclusion of the participant's involvement, where final assessments are conducted to ensure participant safety and gather comprehensive data for analysis.

The expected length of participant involvement is approximately two months, encompassing the screening, treatment, and follow-up phases. 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 trial is conducted under strict adherence to ethical guidelines and regulatory requirements to ensure the integrity of the data and the safety of the participants. The study's design and procedures are meticulously planned to achieve the trial's objectives while maintaining the highest standards of scientific rigor.

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 this clinical trial.

The clinical trial is designed to assess efficacy in a Phase 2 study. The trial is scheduled to commence recruitment on February 1, 2024, with an estimated completion date of March 30, 2024. 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 available 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 the aim of determining 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.