Comparative Bioavailability and Bioequivalence of Oxazepam 50 mg Orodispersible Tablets (Test) Versus Seresta® 50 mg Tablets (Reference): A Single-Dose, Open-Label, Randomized, Two-Sequence, Two-Treatment, Two-Period Crossover Study in Healthy Subjects

The primary objective of this study is to evaluate the **bioequivalence** of Oxazepam 50 mg orodispersible tablets compared to Seresta® 50 mg tablets in healthy subjects. This is a comparative bioavailability study, which is crucial for determining whether the new formulation of Oxazepam is absorbed into the bloodstream at a similar rate and extent as the established Seresta® tablets. Establishing bioequivalence is essential for ensuring therapeutic equivalence, which can impact clinical decision-making and patient outcomes.

The sponsor has not provided information regarding the total number of participants in this clinical trial. The study is a **comparative bioavailability** study and does not investigate any specific medical condition. The trial population includes both male and female subjects, with an age range that corresponds to category code 3, which typically includes adults. The study population selection criteria include a vulnerable population, although specific details on lifestyle considerations such as diet, physical activity, or habits have not been disclosed. The absence of detailed inclusion or exclusion criteria suggests a broad participant selection, but further specifics are not available from the provided data.

The clinical trial is designed to assess the **bioequivalence** of Oxazepam 50 mg orodispersible tablets compared to Seresta® 50 mg tablets in healthy subjects. This study is a Phase 2, randomized, double-blind, controlled trial, which does not investigate any specific medical condition but focuses on comparative bioavailability. The trial is expected to commence recruitment on October 12, 2022, and conclude by November 4, 2022, with the overall duration of the trial being approximately three weeks.

Participants will undergo a series of study visits, beginning with an inclusion visit, also known as the screening visit, where eligibility criteria will be assessed. This visit ensures that only suitable candidates are enrolled in the study. Following the screening, participants will be randomized to receive either the test or reference product under controlled conditions. The trial will include follow-up visits to monitor the participants' health and collect necessary data for bioequivalence analysis. The end-of-study visit will mark the conclusion of the participant's involvement, where final assessments will be conducted to ensure participant safety and gather any remaining data.

The expected length of participant involvement is approximately three weeks, from the initial screening to the end-of-study visit. 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 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 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 offered regarding these aspects of the clinical trial.

The clinical trial is designed to assess efficacy in a Phase 2 study. The trial's estimated recruitment start date was October 12, 2022, with an estimated end date of November 4, 2022. The efficacy assessment will be conducted through a series of planned methods and schedules, although specific parameters or endpoints used to evaluate efficacy, such as symptom improvement scores, biomarker levels, or disease remission rates, are not detailed in the available data. The trial will follow a structured approach to measuring, collecting, and analyzing these efficacy parameters, adhering to the standards expected in clinical research. The trial phase indicates a focus on evaluating the effectiveness and further safety of the intervention, which is typical for Phase 2 studies. The trial category is identified as 1, with a trial category ID of 1466, indicating its classification within the clinical trial framework. The study will proceed without specific mention of tools or instruments involved in efficacy assessments, as these details are not provided in the source material.