Comparative Bioavailability Study of Two Ibuprofen Arginate Formulations in Healthy Volunteers Under Fasting Conditions

The primary objective of this study is to evaluate the **bioavailability** of two formulations of ibuprofen (arginate) when administered as solutions in a single oral dose of 400 mg to healthy subjects under fasting conditions. This is clinically relevant as it helps determine the rate and extent of absorption of the drug, which is crucial for ensuring therapeutic efficacy and safety in clinical 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, specifically between 18 to 65 years. The trial does not include a vulnerable population. The sponsor has not provided information regarding the total number of participants. Participants were selected based on their general health status, ensuring they are free from any significant medical conditions. Lifestyle considerations such as diet, physical activity, and habits were not specified in the available data. Key inclusion or exclusion criteria were not detailed by the sponsor.

The clinical trial is designed as a **randomized**, crossover, two-period, comparative bioavailability study. It aims to evaluate two formulations of ibuprofen (arginate) administered as solutions in a single oral dose of 400 mg to **healthy volunteers** under fasting conditions. The trial is categorized as a Phase 3 study, with an estimated recruitment start date of September 9, 2024, and an anticipated end date of October 31, 2024. The study will involve a sequence of visits, beginning with an inclusion (screening) visit to assess eligibility based on predefined criteria. Participants will then be randomized to receive one of the two formulations in the first period, followed by a washout period, and subsequently receive the alternate formulation in the second period. Follow-up visits will be scheduled to monitor the participants' health status and collect necessary data. The end-of-study visit will conclude the trial, ensuring all data is collected and any adverse events are addressed. The expected length of participant involvement is determined by the trial's crossover design, with each participant completing both periods of the study. 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. The trial's methodology ensures that the study is conducted in a controlled environment, maintaining the integrity and reliability of the collected data.

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 additional relevant aspects of drug administration, dosing schedules, or participant compliance monitoring. The absence of these details limits the ability to describe the treatment regimen comprehensively.

The clinical trial is designed to assess efficacy in a Phase 3 study. The trial is scheduled to commence recruitment on September 9, 2024, with an estimated completion date of October 31, 2024. The efficacy assessment will be conducted using predefined primary and secondary endpoints, although specific endpoints are not detailed in the available data. The trial will follow a structured methodology to ensure the accurate measurement and analysis of efficacy parameters. The data collection and analysis will adhere to rigorous standards typical of Phase 3 trials, ensuring the reliability and validity of the results. The trial's design and execution will be aligned with regulatory requirements and scientific best practices to evaluate the therapeutic benefits effectively.