Bioequivalence Study of Donepezil 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 donepezil 5 mg capsules compared to donepezil 5 mg film-coated tablets. This is assessed after a single oral dose administration to healthy volunteers under fasting conditions. The clinical relevance of this objective lies in ensuring that the two formulations of donepezil, a medication used in the management of **Alzheimer's disease**, have similar bioavailability and therapeutic effects. This is crucial for maintaining consistent treatment outcomes and patient safety when switching between different formulations of the same medication.

The clinical trial involves participants diagnosed with **Alzheimer's 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**, crossover bioequivalence study to compare the pharmacokinetic profiles of donepezil 5 mg capsules versus donepezil 5 mg film-coated tablets. This trial involves a single oral dose administration to healthy volunteers under fasting conditions. The study is conducted in Phase 2 and aims to evaluate the bioequivalence of the two formulations of donepezil, a medication commonly used in the treatment of **Alzheimer's disease**. The trial is expected to commence on February 26, 2024, with an estimated completion date of April 22, 2024, indicating a total duration of approximately two months.

Participants will undergo a series of study visits, beginning with an inclusion visit, also known as the screening visit, where eligibility criteria will be assessed. This visit ensures that only suitable candidates are enrolled in the trial. Following the initial administration of the study drug, participants will attend follow-up visits to monitor their health status and collect necessary pharmacokinetic data. The sequence of these visits is crucial for ensuring the safety and well-being of the participants, as well as for the accurate collection of data. The trial will conclude with an end-of-study visit, where final assessments will be conducted, and participants will be debriefed on their involvement in the study.

The expected length of participant involvement is approximately two months, aligning with the overall trial duration. However, certain conditions may lead to early termination from the study, such as adverse reactions to the study drug, non-compliance with study protocols, or withdrawal of consent by the participant. The trial is conducted under strict ethical guidelines to ensure the safety and rights of all participants are upheld throughout the study period.

The clinical trial documentation does not provide specific details regarding the **experimental medication** used in the study. Information such as the name, pharmaceutical form, dosage, route, and frequency of administration is not available. Additionally, there is no data on whether the medication is a **paediatric formulation** or if it is classified as an **orphan drug**. The maximum daily dose, total dose, and treatment period are also unspecified.

Details about any **non-experimental treatments** used in the study, such as standard-of-care therapy, placebo, or comparator treatment, are not provided. There is no information on the administration of other medicinal products or their role in the trial. Furthermore, the documentation does not include any additional relevant information about drug administration, dosing schedules, or participant compliance monitoring.

The clinical trial is in Phase 2 and is scheduled to begin recruitment on February 26, 2024, with an estimated end date of April 22, 2024. Efficacy will be assessed through the evaluation of primary and secondary endpoints, although specific endpoints are not detailed in the provided data. The trial will follow a structured schedule for measuring and collecting efficacy parameters, which is typical for Phase 2 trials, but the exact methods and tools for these assessments are not specified. The trial's objective is to gather data on the efficacy of the intervention, contributing to the understanding of its potential therapeutic benefits.