Comparative Bioavailability Study of Paracetamol-Ibuprofen Oral Suspension in Healthy Volunteers Under Fasting Conditions

The primary objective of this study is to evaluate the **bioavailability** of two formulations of Paracetamol-Ibuprofen 25-20 mg/ml oral suspension when administered as a single dose to healthy subjects under fasting conditions. This assessment is clinically relevant as it determines the rate and extent to which the active ingredients are absorbed and become available at the site of action, 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. The sponsor did not disclose specific inclusion or exclusion criteria for this trial.

The clinical trial is designed as a **randomized**, crossover, comparative bioavailability study involving two formulations of Paracetamol-Ibuprofen oral suspension. The trial will be conducted with healthy volunteers under fasting conditions. The study is categorized as a Phase 3 trial, with an estimated recruitment start date of April 1, 2025, and an anticipated end date of July 1, 2025. The trial aims to assess the bioavailability of the two formulations when administered as a single dose.

Participants will undergo a sequence of study visits, beginning with an inclusion visit, also known as the screening visit, to determine eligibility based on predefined criteria. Following successful screening, participants will be randomized to receive one of the two formulations. The crossover design ensures that each participant receives both formulations at different times, with a washout period in between to prevent carryover effects. Follow-up visits will be scheduled to monitor the participants' health and collect necessary data for the study's endpoints. The end-of-study visit will conclude the trial, where final assessments will be conducted, and participants will be debriefed.

The expected length of participant involvement is approximately three months, encompassing the screening, treatment, and follow-up phases. Conditions that may lead to early termination from the study include adverse reactions to the study medication, non-compliance with study procedures, or withdrawal of consent by the participant. The trial's design and procedures are structured to ensure the safety and well-being of participants while achieving the study's scientific objectives.

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 this data limits the ability to describe the treatments comprehensively.

The clinical trial is designed to assess efficacy in a Phase 3 study. The trial is scheduled to commence recruitment on April 1, 2025, with an estimated completion date of July 1, 2025. Efficacy will be evaluated using specific parameters or endpoints, although these are not detailed in the provided data. The trial will follow a structured methodology to measure, collect, and analyze these efficacy parameters, adhering to the standards expected in a Phase 3 clinical trial. The trial's design and execution will ensure that the efficacy assessments are conducted with scientific rigor and precision, although specific tools or instruments for these assessments are not mentioned in the available information.