Bioequivalence Study of Apixaban 5 mg Capsules Versus Film-Coated Tablets in Healthy Volunteers Under Fasting Conditions

The primary objective of this study is to evaluate the **bioequivalence** of Apixaban 5 mg capsules compared to Apixaban 5 mg film-coated tablets. This assessment is conducted following a single oral dose administration to healthy volunteers under fasting conditions. Establishing bioequivalence is clinically relevant as it ensures that the two formulations of Apixaban, a medication used in the prevention and treatment of **thrombosis**, have similar bioavailability and therapeutic effects. This is crucial for maintaining consistent efficacy and safety profiles across different formulations of the drug.

The clinical trial focuses on participants diagnosed with **thrombosis**. The study population includes both male and female subjects, with an age range category code of 3, which typically corresponds to adults. The trial does not specifically target a vulnerable population. The sponsor has not provided information regarding the total number of participants involved in the study. Selection criteria, including lifestyle considerations such as diet, physical activity, or habits, have not been disclosed. The trial population was selected without any specified emphasis on particular health statuses or lifestyle factors.

The clinical trial is designed as a **randomized**, crossover bioequivalence study to evaluate the pharmacokinetic properties of Apixaban 5 mg capsules compared to Apixaban 5 mg film-coated tablets. The trial involves a single oral dose administration to healthy volunteers under fasting conditions. The study is conducted in a **double-blind** manner to ensure unbiased results. The trial is categorized as a Phase 2 study, focusing on the condition of **thrombosis**. The estimated recruitment start date is August 21, 2023, with an anticipated end date of September 19, 2023, indicating a short overall trial duration.

Participants will undergo a sequence of study visits, beginning with an inclusion (screening) visit to assess eligibility based on predefined criteria. Following successful screening, participants will be randomized to receive either the capsule or tablet formulation in the first period, followed by a crossover to the alternate formulation in the subsequent period. Each treatment period will be separated by an appropriate washout phase to prevent carryover effects. Follow-up visits will be scheduled 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 one month, considering the time required for screening, treatment periods, and follow-up assessments. Conditions that may lead to early termination from the study include the occurrence of significant adverse events, non-compliance with study procedures, or withdrawal of consent by the participant. The study is conducted in accordance with ethical guidelines and regulatory requirements to ensure the safety and well-being of all participants.

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

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 cannot be provided.

Additional relevant information about drug administration, dosing schedules, and participant compliance monitoring is also not included in the provided data. As such, these aspects cannot be detailed in the current context.

The clinical trial is designed to assess efficacy in a Phase 2 study. The trial is scheduled to begin recruitment on August 21, 2023, with an estimated end date of September 19, 2023. The efficacy assessment will be conducted using predefined primary and secondary endpoints, although specific endpoints are not detailed in the available data. The trial will follow a structured methodology to ensure accurate and reliable measurement of efficacy parameters. The collection and analysis of data will adhere to standard clinical trial protocols, ensuring the integrity and validity of the results. The trial's design and execution will be aligned with regulatory requirements and scientific standards to evaluate the therapeutic potential of the investigational product.