Pharmacokinetic Study of Alverine Citrate/Simeticone 60 mg/300 mg Soft Capsules in Healthy Subjects Under Fed Conditions

The primary objective of this study is to evaluate the **bioavailability** of Alverine citrate/Simeticone 60 mg/300 mg soft capsules compared to Meteospasmyl 60 mg/300 mg soft capsules in healthy male and female subjects under fed conditions. This is clinically relevant as it assesses the pharmacokinetic profile of the test formulation, which is crucial for determining its therapeutic equivalence and ensuring consistent efficacy and safety in clinical use.

The clinical trial involves a study population comprising **healthy subjects** participating in a bioavailability study. The age range of participants is categorized under code "3," which typically includes adults. The trial includes both **female** and **male** subjects, indicating a gender-diverse cohort. The trial population selection criteria include a focus on healthy individuals, with no specific medical conditions being targeted, as the study is not disease-specific. The sponsor has not provided the total number of participants involved in the trial. Additionally, the trial includes a **vulnerable population**, although specific details regarding lifestyle considerations such as diet, physical activity, or habits have not been disclosed. The sponsor has not provided detailed inclusion or exclusion criteria for this study.

The clinical trial is designed as an **open label**, randomized, single dose, two-sequence, two-treatment, four-period, fully replicate, cross-over pharmacokinetic study. The trial aims to compare the bioavailability of Alverine citrate/Simeticone 60 mg/300 mg soft capsules to Meteospasmyl 60 mg/300 mg soft capsules in healthy male and female subjects under fed conditions. The study is categorized as a Phase 2 trial and is expected to commence recruitment on October 21, 2024, with an estimated completion date of December 3, 2024.

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 the two treatment sequences. The trial involves four periods, during which each participant will receive both treatments in a cross-over manner, allowing for a comprehensive comparison of the pharmacokinetic profiles. Each treatment period will be separated by an appropriate washout phase to ensure no carryover effects.

Throughout the trial, follow-up visits will be conducted to monitor the participants' health status and collect necessary pharmacokinetic data. The end-of-study visit will mark the conclusion of the participant's involvement, during which final assessments will be performed to ensure participant safety and gather any remaining data. The expected length of participant involvement is determined by the duration of the four treatment periods and the washout intervals.

Participants may be subject to early termination from the study if they experience adverse events that compromise their safety, fail to comply with study procedures, or withdraw consent. The trial is conducted in accordance with ethical standards and regulatory requirements to ensure the safety and well-being of all participants.

The clinical trial documentation does not provide specific details regarding the experimental medication, including its name, pharmaceutical form, dosage, route, or frequency of administration. As such, no detailed description of the experimental treatment can be provided based on the available data.

Similarly, there is no information available about any non-experimental treatments used in the study, such as standard-of-care therapy, placebo, or comparator treatment. Consequently, no description of these elements can be included.

Additional relevant information about drug administration, dosing schedules, and participant compliance monitoring is also not provided in the source data. Therefore, no further details can be elaborated upon in this context.

The clinical trial is designed to assess efficacy through a structured evaluation process. The trial is categorized as a Phase 2 study, indicating its focus on evaluating the efficacy and side effects of the intervention. The estimated recruitment start date is October 21, 2024, with an anticipated end date of December 3, 2024. Although specific efficacy parameters such as primary and secondary endpoints are not detailed, Phase 2 trials typically involve measuring clinical outcomes related to the disease being studied. These may include symptom improvement scores, biomarker levels, or disease remission rates, depending on the condition under investigation. The methods for measuring and analyzing these parameters are expected to align with standard clinical trial practices, utilizing validated scales, laboratory tests, or patient-reported outcomes at predetermined timepoints throughout the study duration. The trial's design and execution will adhere to rigorous scientific standards to ensure the reliability and validity of the efficacy assessments.