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

The primary objective of this study is to evaluate the **bioequivalence** of apixaban 5 mg hard capsules (PG412 [Celon Pharma]) compared to apixaban 5 mg film-coated tablets (Eliquis [Bristol-Myers Squibb]) under fasting conditions in healthy volunteers. This is clinically relevant as apixaban is used for the prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (NVAF) who have one or more risk factors, such as prior stroke or transient ischemic attack (TIA), age ≥ 75 years, hypertension, diabetes mellitus, or symptomatic heart failure (NYHA Class ≥ II). Additionally, apixaban is indicated for the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), as well as the prevention of recurrent DVT and PE in adults. The study aims to ensure that the new formulation of apixaban is therapeutically equivalent to the existing formulation, thereby providing an alternative option for patients requiring anticoagulation therapy.

The clinical trial involves a study population comprising both **male** and **female** participants, with an age range category code of 3, indicating adults. The trial focuses on the **prevention of stroke** and systemic embolism in adult patients with non-valvular atrial fibrillation (NVAF) who have one or more risk factors, such as prior stroke or transient ischaemic attack (TIA), age 75 years or older, hypertension, diabetes mellitus, or symptomatic heart failure classified as NYHA Class II or higher. Additionally, the trial addresses the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), as well as the prevention of recurrent DVT and PE in adults. The trial does not include a vulnerable population. The sponsor has not provided information regarding the total number of participants or specific lifestyle considerations such as diet or physical activity.

The clinical trial is designed as a **randomized**, open-label, single-dose, 2-way crossover bioequivalence study. It aims to compare the pharmacokinetic profiles of apixaban 5 mg hard capsules (PG412 [Celon Pharma]) with apixaban 5 mg film-coated tablets (Eliquis [Bristol-Myers Squibb]) under fasting conditions in healthy volunteers. The trial is categorized as a Phase 2 study and is expected to commence recruitment on August 26, 2024, with an estimated completion date of September 23, 2024. The primary medical conditions of interest include the prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (NVAF) and the treatment and prevention of deep vein thrombosis (DVT) and pulmonary embolism (PE).

Participants will undergo a series 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 test or reference formulation in a crossover manner. Each treatment period will be separated by an appropriate washout period to ensure no carryover effects. Follow-up visits will be scheduled to monitor safety and collect pharmacokinetic data. The end-of-study visit will conclude the trial, where final assessments will be conducted to ensure participant safety and gather any remaining data.

The expected length of participant involvement is determined by the duration of the crossover periods and the washout interval, typically spanning several weeks. 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 is conducted under strict adherence to ethical guidelines and regulatory requirements to ensure the safety and well-being of all participants.

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 commence recruitment on August 26, 2024, with an estimated end date of September 23, 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 treatment's impact on the specified medical condition, utilizing appropriate clinical methodologies and tools as per standard Phase 2 trial protocols. The trial's design will adhere to rigorous scientific standards to ensure the reliability and validity of the efficacy outcomes.