Bioequivalence Study of 600 mg Ibuprofen: Comparison of Ibuprofen Sopharma and Brufen in a Monocentric, Open, Randomized, Crossover Trial in Healthy Volunteers

The primary objective of this clinical trial is to evaluate the **bioequivalence** of two pharmaceutical products containing 600 mg of **ibuprofen**: Ibuprofen Sopharma 600 mg film-coated tablets (Test) and Brufen 600 mg film-coated tablets (Comparator). This study is conducted in healthy volunteers to ensure that the pharmacokinetic profiles of the two formulations are comparable, which is crucial for confirming that the Test product can be used interchangeably with the Comparator without compromising efficacy or safety. There are no secondary objectives specified for this trial.

The clinical trial involves **healthy volunteers** with no specific therapeutic indication. The study population includes both male and female participants, with an age range categorized as 3, which typically corresponds to adults. The trial does not involve 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 to evaluate the **bioequivalence** of two products containing 600 mg of **ibuprofen**: Ibuprofen Sopharma 600 mg film-coated tablets (Test) and Brufen 600 mg film-coated tablets (Comparator). This is a monocentric, open, randomized, single-dose, two-period, crossover trial conducted in healthy volunteers. The trial is categorized as a Phase 2 study and does not have a therapeutic indication, as it involves healthy participants. The estimated recruitment start date is August 1, 2025, with an anticipated end date of September 30, 2025, indicating a total trial duration of approximately two months.

The trial involves a sequence of study visits, beginning with an inclusion (screening) visit to assess eligibility based on predefined criteria. Participants will then be randomized to receive either the test or comparator product in the first period, followed by a washout period, and subsequently receive the alternate product in the second period. Each participant will attend follow-up visits after each dosing period to monitor safety and collect pharmacokinetic data. The end-of-study visit will occur after the completion of both dosing periods and all necessary follow-up assessments.

Participant involvement is expected to last for the entire duration of the trial, approximately two months, including all visits and assessments. Conditions that may lead to early termination from the study include non-compliance with study procedures, adverse events that compromise participant safety, or withdrawal of consent. The trial is conducted under strict adherence to ethical guidelines and regulatory requirements to ensure the safety and well-being of all participants.

The clinical trial involves the administration of an **experimental medication**. However, specific details regarding the name, pharmaceutical form, dosage, route, and frequency of administration of the experimental medication are not provided in the available data. The trial documentation does not specify whether the medication is a **paediatric formulation** or if it is classified as an **orphan drug**. Additionally, there is no information on the maximum daily dose, total dose, or treatment period for the experimental medication.

In addition to the experimental medication, the trial may include the use of **non-experimental treatments** such as standard-of-care therapy, placebo, or comparator treatments. However, the data does not provide explicit details about these treatments, including their names, dosages, or administration routes. The trial documentation does not specify any additional relevant information about drug administration, dosing schedules, or participant compliance monitoring.

The clinical trial is designed to assess efficacy in a Phase 2 study. The trial is scheduled to commence recruitment on August 1, 2025, with an estimated completion date of September 30, 2025. Efficacy will be evaluated using specific parameters or endpoints, although these are not detailed in the provided data. The methods and schedule for measuring, collecting, and analyzing these efficacy parameters are not specified. The trial will adhere to standard practices for Phase 2 studies, focusing on determining the efficacy of the intervention under investigation. The trial's design and execution will follow rigorous scientific and ethical standards to ensure the reliability and validity of the results.