Comparative Bioavailability Study of Ibuprofen (Arginine) Granules Versus Espidifen® in Healthy Volunteers Under Fasting Conditions

The primary objective of this study is to evaluate the **bioavailability** of ibuprofen (arginine) granules for oral solution developed by Farmalider, S.A., in comparison to Espidifen® granules for oral solution. This evaluation is conducted in healthy subjects under fasting conditions, with a single dose of 600 mg administered. The clinical relevance of this study lies in determining the pharmacokinetic profile of the new formulation, which is crucial for ensuring its efficacy and safety in therapeutic use.

The clinical trial involves **healthy volunteers** as the study population, encompassing both male and female participants. The age range of the participants is categorized as adults, although specific age limits are not provided. The sponsor has not disclosed the total number of participants involved in the trial. The selection process for the trial population is not detailed, and there is no information regarding specific lifestyle considerations such as diet, physical activity, or habits. The trial does not focus on a vulnerable population, and no significant inclusion or exclusion criteria have been highlighted by the sponsor.

The clinical trial is designed as a **randomized**, crossover, two-period, two-treatment, comparative bioavailability study. It involves the administration of ibuprofen (arginine) granules for oral solution and Espidifen® granules for oral solution, each in a single dose of 600 mg, to **healthy volunteers** under fasting conditions. The trial is categorized as a Phase 3 study and is expected to commence recruitment on March 11, 2024, with an estimated completion date of May 10, 2024. The trial aims to assess the bioavailability of the two formulations in a controlled environment.

Participants will undergo a sequence of study visits, beginning with an inclusion (screening) visit to determine eligibility based on predefined criteria. Following successful screening, participants will be randomized to receive one of the two treatments in the first period, followed by a washout phase, and then crossover to the alternate treatment in the second period. Each treatment period will be separated by a sufficient washout period to ensure no carryover effects. The end-of-study visit will occur after the completion of both treatment periods, where final assessments will be conducted to evaluate the primary and secondary endpoints of the study.

The expected length of participant involvement is approximately two months, encompassing the screening, treatment, and follow-up phases. 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.

The clinical trial documentation does not provide specific details regarding the experimental medication, including its name, pharmaceutical form, dosage, route, or frequency of administration. Consequently, no detailed description of the experimental treatment can be provided based on the available data.

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. As such, no description of these elements can be included.

Additional relevant information about drug administration, dosing schedules, and participant compliance monitoring is also absent from the provided data. Therefore, no further details can be offered in this context.

The clinical trial is in Phase 3 and is scheduled to have an estimated recruitment start date of March 11, 2024, with an estimated end date of May 10, 2024. The efficacy of the intervention will be assessed through a structured evaluation process, although specific parameters or endpoints for efficacy assessment are not detailed in the provided data. The trial will follow a systematic approach to measure, collect, and analyze efficacy data, adhering to the standards expected in a Phase 3 clinical trial. The trial's design will ensure that efficacy assessments are conducted at predetermined timepoints, utilizing appropriate tools and instruments to ensure the reliability and validity of the collected data. The trial will be conducted in accordance with regulatory guidelines to ensure the integrity and scientific validity of the efficacy outcomes.