Bioequivalence Study of Atorvastatin 80 mg Capsules vs. Film-Coated Tablets in Hypercholesterolaemia and Cardiovascular Disease Prevention

The primary objective of this study is to evaluate the **bioequivalence** of atorvastatin 80 mg capsules compared to atorvastatin 80 mg film-coated tablets. This assessment is conducted following a single oral dose administration to healthy volunteers under fasting conditions, utilizing a crossover replicated design. The clinical relevance of this study lies in its potential to confirm that the two formulations of atorvastatin are interchangeable, which is crucial for ensuring consistent therapeutic outcomes in the management of **hypercholesterolaemia** and the prevention of **cardiovascular disease**. No secondary objectives are specified for this trial.

The clinical trial involves participants diagnosed with **hypercholesterolaemia** and aims at the prevention of cardiovascular disease. The study population includes both male and female subjects, with an age range categorized as adults. The trial does not specifically target a vulnerable population. The sponsor has not provided information regarding the total number of participants. Selection criteria for the trial population, as well as any relevant lifestyle considerations such as diet, physical activity, or habits, have not been disclosed. Key inclusion or exclusion criteria are also not specified by the sponsor.

The clinical trial is designed as a **randomized**, bioequivalence study comparing atorvastatin 80 mg capsules to atorvastatin 80 mg film-coated tablets. This trial will be conducted in a crossover replicated design, involving healthy volunteers who will receive a single oral dose under fasting conditions. The study aims to evaluate the bioequivalence of the two formulations in the context of **hypercholesterolaemia** and the prevention of cardiovascular disease. The trial is categorized as a Phase 2 study and is expected to commence recruitment on June 1, 2024, with an estimated completion date of July 2, 2024.

Participants will undergo a series of study visits, beginning with an inclusion visit, which serves as the screening phase 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 washout phase, and then crossover to the alternate formulation in the subsequent period. 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 duration of participant involvement is approximately one month, accounting for the initial screening, dosing periods, and follow-up assessments. Conditions that may lead to early termination from the study include non-compliance with study procedures, withdrawal of consent, or the occurrence of significant adverse events that compromise participant safety. The trial is structured to maintain scientific rigor and ensure the reliability of the results, adhering to ethical standards and regulatory requirements.

The clinical trial involves the administration of an **experimental medication**. However, specific details regarding the name, pharmaceutical form, dosage, route, and frequency of administration of the experimental medication are not provided in the available data. The trial documentation does not specify whether the medication is a **paediatric formulation** or if it is classified as an **orphan drug**. Additionally, there is no information on the maximum daily dose, total dose, or treatment period for the experimental medication.

In addition to the experimental medication, the trial may include the use of **non-experimental treatments** such as standard-of-care therapy, placebo, or comparator treatment. However, the data does not provide explicit details about these treatments. Information regarding the administration, dosing schedules, and participant compliance monitoring for these non-experimental treatments is also not available.

Due to the lack of specific information, further details about the **experimental medication** and any **non-experimental treatments** used in the study cannot be provided. The trial documentation does not include any additional relevant information about drug administration or participant compliance monitoring.

The clinical trial is in Phase 2 and is scheduled to begin recruitment on June 1, 2024, with an estimated end date of July 2, 2024. Efficacy will be assessed using specific parameters or endpoints, although these are not detailed in the provided data. The trial will likely involve the collection and analysis of data at predetermined timepoints throughout the study duration. The methods and tools for measuring efficacy, such as validated scales or laboratory tests, are not specified in the available information. The trial's focus is on evaluating the efficacy of an intervention, but further details on the endpoints or assessment tools are not provided.