Bioequivalence Study of Paracetamol Orodispersible Tablet 500 mg Versus Alvedon and Panadol 500 mg Film-Coated Tablets in Healthy Adults

The primary objective of this study is to evaluate the **bioequivalence** of a 500 mg Paracetamol Orodispersible Tablet with two reference products: Alvedon 500 mg Film-Coated Tablet and Panadol 500 mg Film-Coated Tablet. This assessment is conducted in healthy adult subjects under fasting conditions. Establishing bioequivalence is clinically relevant as it ensures that the new formulation of Paracetamol provides the same therapeutic effect and safety profile as the existing formulations, thereby supporting its use as an interchangeable treatment option.

The clinical trial involves **healthy volunteers** with no specific therapeutic indication being studied. The study population includes both male and female participants, with an age range category code of 3, which typically corresponds to adults. The trial population was selected to include a vulnerable population, although specific details regarding the selection process or lifestyle considerations such as diet, physical activity, or habits are not provided. The sponsor has not disclosed the total number of participants involved in the trial. Key inclusion or exclusion criteria are not specified in the available data.

The clinical trial is designed as a **randomized**, open-label, single-center, single oral dose, three-treatment, three-period, three-sequence, change-over bioequivalence study. The trial aims to assess the bioequivalence of a 500 mg paracetamol orodispersible tablet with two other formulations: Alvedon 500 mg film-coated tablet and Panadol 500 mg film-coated tablet. The study will be conducted in healthy adult subjects under fasting conditions. The trial is expected to commence on February 3, 2025, and conclude by March 6, 2025, with the total duration of the trial spanning approximately one month.

Participants will undergo a series of study visits, beginning with an inclusion (screening) visit to determine eligibility based on predefined criteria. Following successful screening, participants will be randomized into one of the three treatment sequences. Each treatment period will involve the administration of a single oral dose of the assigned formulation, followed by a washout period before the next treatment period begins. The purpose of these visits is to monitor the pharmacokinetic parameters and ensure the safety and well-being of the participants. The end-of-study visit will occur after the final treatment period, where final assessments will be conducted to gather comprehensive data on the bioequivalence of the formulations.

The expected length of participant involvement is approximately one month, encompassing all treatment periods and follow-up assessments. Conditions that may lead to early termination from the study include adverse events that compromise participant safety, 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 integrity and validity of the trial outcomes.

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

Similarly, there is no information available about any non-experimental treatments used in the study, such as standard-of-care therapy, placebo, or comparator treatment. Therefore, a description of these elements is not possible based on the current data.

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

The clinical trial is designed to assess efficacy in a Phase 2 study. The trial is scheduled to commence recruitment on February 3, 2025, with an estimated completion date of March 6, 2025. The efficacy assessment will be conducted using predefined endpoints, although specific parameters or endpoints are not detailed in the provided data. The trial will follow a structured methodology to ensure accurate and reliable data collection and analysis. The schedule for measuring and collecting efficacy data is not specified, and no specific tools or instruments for efficacy assessments are mentioned. The trial's focus is on evaluating the efficacy of the intervention within the context of its Phase 2 categorization, which typically involves assessing the treatment's effectiveness and further evaluating its safety profile.