Bioequivalence Study of Amoxicillin/Clavulanic Acid Formulations in Healthy Volunteers Under Fed Conditions

The primary objective of this study is to evaluate the **bioequivalence** of Taromentin® 500 mg + 125 mg film-coated tablets compared to Augmentin® 500 mg + 125 mg film-coated tablets in healthy volunteers under fed conditions. This is clinically relevant as establishing bioequivalence ensures that the generic formulation, Taromentin®, is therapeutically equivalent to the reference product, Augmentin®, which is widely used in the treatment of **infections**. The study aims to confirm that both formulations deliver the same therapeutic effect, which is crucial for ensuring patient safety and efficacy in clinical practice.

The clinical trial involves a study population comprising both **male** and **female** participants, with an age range categorized under code "3," which typically includes adults. The trial includes individuals from a **vulnerable population**, indicating that special considerations are in place to ensure their safety and ethical treatment. The study focuses on participants with **infections** as the primary medical condition of interest. However, the sponsor has not provided specific information regarding the total number of participants involved in the trial. The selection process for the trial population, as well as any lifestyle considerations such as diet, physical activity, or habits, have not been disclosed. Additionally, key inclusion or exclusion criteria have not been specified by the sponsor.

The clinical trial is designed as a **randomized**, open-label, two-period, two-sequence, crossover study to evaluate the bioequivalence of Taromentin® 500 mg + 125 mg film-coated tablets compared to Augmentin® 500 mg + 125 mg film-coated tablets in healthy volunteers under fed conditions. The trial is categorized as a Phase 2 study and is expected to commence recruitment on June 23, 2025, with an estimated completion date of August 8, 2025. The primary medical condition under investigation is **infections**, with specific focus on conditions such as urinary tract infections and acute respiratory tract infections.

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 of the medication in 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, encompassing the screening, treatment, and follow-up phases. 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 study is structured to ensure rigorous data collection and analysis, adhering to ethical standards and regulatory requirements.

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, further details about the **experimental medication** and any **non-experimental treatments** used in the study cannot be provided. The trial documentation does not include any additional relevant information about drug administration 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 June 23, 2025, with an estimated completion date of August 8, 2025. The efficacy assessment will be conducted in accordance with the trial's protocol, which is structured to evaluate the therapeutic impact of the investigational product. The specific parameters or endpoints for efficacy evaluation, as well as the methods and schedule for measuring, collecting, and analyzing these parameters, are not detailed in the provided data. The trial will adhere to rigorous scientific standards to ensure the reliability and validity of the efficacy outcomes.