Comparative Bioavailability Study of UDCA PMCS 500 mg Formulations in Healthy Volunteers Under Fasting Conditions

The primary objective of this study is to evaluate the **bioavailability** of three different formulations of UDCA PMCS 500 mg film-coated tablets compared to a reference formulation in healthy male and female volunteers under fasting conditions. This is clinically relevant as understanding the bioavailability of these formulations can inform dosing strategies and optimize therapeutic outcomes for conditions where UDCA is indicated, such as the dissolution of cholesterol gallstones. The study is designed as a pilot, open-label, single-dose, randomized, four-period, four-sequence, four-treatment crossover trial.

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 does not specifically target a vulnerable population. The sponsor has not provided information regarding the total number of participants. The selection criteria for the trial population have not been disclosed, and there are no specific lifestyle considerations such as diet or physical activity mentioned. The study focuses on the medical condition related to the reduction of cholesterol saturation in bile, which is relevant for conditions involving cholesterol gallstones. Key inclusion or exclusion criteria have not been specified by the sponsor.

The clinical trial is designed as a **pilot, open-label, single-dose, randomized, four-period, four-sequence, four-treatment crossover** study. It aims to compare the bioavailability of three different formulations of UDCA PMCS 500 mg film-coated tablets with a reference formulation in healthy male and female volunteers under fasting conditions. The trial is categorized as a Phase 2 study and is expected to commence recruitment on February 10, 2025, with an estimated completion date of April 30, 2025.

Participants will undergo a series of study visits, beginning with an inclusion visit, where eligibility will be assessed based on predefined criteria. Following successful screening, participants will be randomized to receive the study treatments in a crossover manner. Each treatment period will be separated by an appropriate washout period to ensure no carryover effects. The primary purpose of these visits is to evaluate the pharmacokinetic parameters of the different formulations.

The expected duration of participant involvement in the study is determined by the completion of all four treatment periods, including follow-up assessments. Participants may be withdrawn from the study if they experience adverse events that compromise their safety, fail to comply with study procedures, or withdraw consent. The end-of-study visit will involve final assessments to ensure participant safety and collect any remaining data.

In this clinical trial, the experimental medication and non-experimental treatments have not been specified in the provided data. Therefore, a detailed description of the experimental medication, including its name, pharmaceutical form, dosage, route, and frequency of administration, cannot be provided. Similarly, information regarding any non-experimental treatments, such as standard-of-care therapy, placebo, or comparator treatment, is not available.

Additional relevant information about drug administration, dosing schedules, and participant compliance monitoring is also not included in the source data. Consequently, a comprehensive description of the treatments used in this clinical trial cannot be constructed based on the current information.

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 in a specific patient population. The trial is scheduled to commence recruitment on February 10, 2025, with an estimated end date of April 30, 2025. Although specific efficacy parameters such as primary or secondary endpoints are not detailed, Phase 2 trials generally involve measuring clinical outcomes that may include symptom improvement scores, biomarker levels, or disease remission rates. The methods for measuring, collecting, and analyzing these parameters are not specified, but they often involve validated scales, laboratory tests, or patient-reported outcomes. The trial's efficacy assessments are expected to be conducted at predetermined timepoints throughout the study duration, ensuring a comprehensive evaluation of the treatment's impact on the targeted medical condition.