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

The primary objective of this study is to evaluate the **bioavailability** of two different formulations of **ibuprofen** when administered as a single oral dose of 400 mg in solution form to healthy subjects under fasting conditions. This is clinically relevant as it helps determine the absorption rate and extent of the drug, which is crucial for ensuring therapeutic efficacy and safety. No secondary objectives are provided in the available data.

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 focus on a vulnerable population, ensuring a general representation of healthy individuals. The sponsor has not provided information regarding the total number of participants involved in the study. Participants were selected based on their general health status, with no specific lifestyle considerations such as diet or physical activity being highlighted. The selection process did not emphasize any particular habits or lifestyle factors, maintaining a broad inclusion of healthy adults.

The clinical trial is designed as a **randomized**, crossover, two-period, comparative bioavailability study. It aims to evaluate two formulations of **ibuprofen** following a single oral dose of 400 mg in solution form administered to healthy subjects under fasting conditions. The trial is categorized as a Phase 3 study and is expected to commence recruitment on May 1, 2025, with an estimated completion date of June 30, 2025. The study involves healthy volunteers, and the trial's duration is approximately two months, encompassing the recruitment and study phases.

Participants will undergo a series of study visits, beginning with an inclusion visit, also known as the screening visit, to assess eligibility based on predefined criteria. Following successful screening, participants will be randomized to receive one of the two ibuprofen formulations. The study design includes a crossover mechanism, where each participant will receive both formulations in separate periods, allowing for direct comparison within the same individual. The crossover periods will be separated by an appropriate washout period to prevent carryover effects.

Throughout the trial, participants will attend follow-up visits to monitor safety, adherence, and any adverse events. These visits are crucial for collecting pharmacokinetic data and ensuring the integrity of the study. The end-of-study visit will mark the conclusion of the participant's involvement, where final assessments will be conducted, and any remaining queries will be addressed. The expected length of participant involvement is contingent upon the completion of both crossover periods and all associated visits.

Conditions that may lead to early termination from the study include non-compliance with study procedures, the occurrence of significant adverse events, or withdrawal of consent by the participant. The study is conducted under strict adherence to ethical guidelines and regulatory requirements to ensure participant safety and data validity.

The clinical trial documentation does not provide specific details regarding the experimental medication, including its name, pharmaceutical form, dosage, route, or frequency of administration. As such, 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. Consequently, no description of these elements can be included.

Additional relevant information about drug administration, dosing schedules, and participant compliance monitoring is also not provided in the source data. Therefore, no further details can be elaborated upon in this context.

The clinical trial is designed to assess efficacy in a Phase 3 study. The trial is scheduled to commence recruitment on May 1, 2025, with an estimated completion date of June 30, 2025. Efficacy will be evaluated using specific parameters or endpoints, although these are not detailed in the provided data. The trial will likely involve systematic methods for measuring, collecting, and analyzing these efficacy parameters, consistent with standard practices in Phase 3 trials. These may include validated scales, laboratory tests, or patient-reported outcomes, measured at predetermined timepoints throughout the study duration. The trial's design and execution will adhere to rigorous scientific and ethical standards to ensure the reliability and validity of the efficacy assessments.