Bioequivalence Study of Amoxicillin and Clavulanic Acid Oral Suspension in Healthy Volunteers Under Fed Conditions

The primary objective of this study is to evaluate the **bioequivalence** of a single-dose formulation of 400 mg/5 mL **amoxicillin** combined with 57 mg/5 mL of **clavulanic acid** powder for oral suspension in healthy volunteers under fed conditions. This is clinically relevant as establishing bioequivalence ensures that the new formulation provides the same therapeutic effect and safety profile as the existing standard, which is crucial for effective treatment of **infections**. No secondary objectives are provided in the available data.

The clinical trial involves a study population that includes both **male** and **female** participants, with an age range categorized as "3," which typically corresponds to adults. The trial population is noted to include a **vulnerable population**, although specific details regarding the nature of this vulnerability are not provided. The total number of participants in the study is not disclosed, as the sponsor has not provided this information. Participants are selected based on unspecified criteria, and no specific lifestyle considerations such as diet, physical activity, or habits are mentioned. The study focuses on individuals with an **infection**, but further details regarding the type or severity of the infection are not available. Key inclusion or exclusion criteria are not specified in the provided data.

The clinical trial is designed as a **randomized**, open-label, two-period, two-sequence, crossover study to evaluate the bioequivalence of a single dose of 400 mg/5 mL amoxicillin combined with 57 mg/5 mL of clavulanic acid powder for oral suspension. The study will be conducted under fed conditions in healthy volunteers. The trial is categorized as a Phase 2 study and is expected to commence recruitment on September 1, 2025, with an estimated completion date of November 8, 2025. The primary medical condition under investigation is **infection**, specifically focusing on acute upper respiratory infections of multiple or unspecified sites.

Participants will undergo a series of study visits, beginning with an inclusion visit, which serves as the screening phase to assess eligibility based on predefined criteria. Following successful screening, participants will be randomized into one of two sequences for the crossover design. Each participant will receive both formulations in two separate periods, with a washout phase in between to prevent carryover effects. The study will include follow-up visits to monitor safety and collect pharmacokinetic data. The end-of-study visit will conclude the participant's involvement, ensuring all necessary data is collected and any adverse events are addressed.

The expected duration of participant involvement is approximately two months, accounting for the screening, treatment, and follow-up phases. Conditions that may lead to early termination from the study include non-compliance with study procedures, adverse reactions to the investigational product, or withdrawal of consent by the participant. The study aims to ensure the safety and well-being of participants while providing valuable data on the bioequivalence of the investigational product.

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. Information regarding the administration, dosing schedules, and participant compliance monitoring for these non-experimental treatments is also not available.

Due to the lack of specific information in the source data, further details about the **experimental medication** and any **non-experimental treatments** cannot be provided. The trial documentation should be consulted for comprehensive information regarding the treatments used in this clinical trial.

The clinical trial is designed to assess efficacy through a structured evaluation process. The trial is categorized as a Phase 2 study, which typically focuses on assessing the efficacy of a treatment and further evaluating its safety. The trial is scheduled to commence recruitment on September 1, 2025, with an estimated end date of November 8, 2025. Although specific efficacy parameters such as primary and secondary endpoints are not detailed, Phase 2 trials generally involve measuring clinical outcomes that demonstrate the treatment's effect on the disease. These may include symptom improvement scores, biomarker levels, or disease remission rates, depending on the condition being studied. The methods for measuring and analyzing these parameters are typically standardized and may involve validated scales, laboratory tests, or patient-reported outcomes collected at predefined timepoints throughout the trial. The data collected will be analyzed to determine the treatment's efficacy in achieving the desired clinical outcomes.