Bioavailability Comparison of Teriflunomide 14 mg Film-Coated Tablets: Single-Dose, Open-Label, Randomized Crossover Study in Healthy Subjects Under Fasting Conditions

The primary objective of this study is to evaluate the **bioavailability** of Teriflunomide 14 mg film-coated tablets in healthy subjects under fasting conditions. This is a critical assessment as it determines the extent and rate at which the active drug ingredient is absorbed and becomes available at the site of action. Understanding the bioavailability of Teriflunomide is clinically relevant as it informs dosing regimens and ensures therapeutic efficacy while minimizing potential side effects. The study is designed as a single-dose, open-label, randomized, two-sequence, two-treatment, two-period crossover study, which allows for a comprehensive comparison of the drug's pharmacokinetic profile.

The clinical trial involves a study population consisting exclusively of **male** participants, with an **age range** categorized as adults. The sponsor has not provided information regarding the total number of participants. The trial population was selected without targeting any specific medical condition, as the study does not focus on individuals with pre-existing health issues. Participants are not considered part of a vulnerable population. The selection process did not emphasize any particular lifestyle considerations such as diet, physical activity, or habits. The sponsor has not disclosed any key inclusion or exclusion criteria for this trial.

The clinical trial is designed as a **randomized**, open-label, two-sequence, two-treatment, two-period crossover study to evaluate the comparative bioavailability of Teriflunomide 14 mg film-coated tablets in healthy subjects under fasting conditions. The trial is categorized as a Phase 2 study and does not involve any specific medical condition. The estimated recruitment start date is December 14, 2024, with an anticipated end date of February 4, 2025. The trial involves a sequence of study visits, beginning with an inclusion visit where participants are screened for eligibility based on predefined criteria. Following successful screening, participants will be randomized into one of two sequences, receiving the investigational product in a crossover manner across two periods. Each treatment period will be separated by a washout phase to ensure no carryover effects. The study will include follow-up visits to monitor safety and collect pharmacokinetic data. The end-of-study visit will conclude the trial, where final assessments will be conducted, and data will be collected for analysis. The expected length of participant involvement is determined by the duration of the crossover periods and the washout phase. Conditions that may lead to early termination from the study include adverse events, non-compliance with study procedures, or withdrawal of consent by the participant. The trial's methodology ensures rigorous data collection and analysis to achieve the study's objectives while maintaining participant safety and adherence to ethical standards.

The clinical trial documentation does not provide specific details regarding the experimental medication, including its name, pharmaceutical form, dosage, route, and 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 treatments 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 in a Phase 2 study. The trial is scheduled to commence recruitment on December 14, 2024, with an estimated completion date of February 4, 2025. The efficacy assessment will be conducted using predefined parameters, although specific endpoints and methods for measuring efficacy are not detailed in the available data. The trial will follow a structured timeline to ensure systematic data collection and analysis. The focus will be on evaluating the treatment's impact over the course of the study, adhering to the protocols typical of a Phase 2 trial. The trial's design will ensure that efficacy is assessed in a manner consistent with clinical research standards, although specific tools or instruments for efficacy assessments are not mentioned.