Bioequivalence Study of Escitalopram 10 mg Capsules Versus Film-Coated Tablets in Healthy Volunteers Under Fasting Conditions

The primary objective of this study is to evaluate the **bioequivalence** of escitalopram 10 mg capsules compared to escitalopram 10 mg film-coated tablets. This is assessed after a single oral dose administration to healthy volunteers under fasting conditions. Establishing bioequivalence is clinically relevant as it ensures that the two formulations of escitalopram, an **antidepressant**, have similar bioavailability and therapeutic effects, which is crucial for maintaining consistent treatment outcomes in patients.

The clinical trial involves participants diagnosed with conditions related to **antidepressants**. The study population includes both male and female subjects, with an age range categorized under code "3". The total number of participants is not provided, as the sponsor did not give this information. The trial population was selected without targeting a vulnerable population. No specific lifestyle considerations such as diet, physical activity, or habits are mentioned. Key inclusion or exclusion criteria are not detailed in the available data.

The clinical trial is designed as a **randomized**, crossover bioequivalence study to compare the pharmacokinetic profiles of escitalopram 10 mg capsules and escitalopram 10 mg film-coated tablets. The trial will involve healthy volunteers who will receive a single oral dose of each formulation under fasting conditions. The study is categorized as a Phase 2 trial and is expected to commence recruitment on June 16, 2025, with an estimated completion date of August 25, 2025.

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 to receive one of the two formulations. The crossover design ensures that each participant receives both formulations, with a washout period between administrations to prevent carryover effects. Follow-up visits will be scheduled to monitor the participants' health status and collect pharmacokinetic data at specified time points post-dosing.

The end-of-study visit will conclude the trial, during which final assessments will be conducted to ensure participant safety and gather any remaining data. The expected duration of participant involvement is approximately three months, accounting for the screening, dosing, washout, and follow-up periods. 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.

No specific information regarding the experimental medication, including its name, pharmaceutical form, dosage, route, and frequency of administration, is provided in the available data. Consequently, a detailed description of the experimental treatment cannot be formulated based on the current dataset.

Similarly, there is no information available about any non-experimental treatments, such as standard-of-care therapy, placebo, or comparator treatment, used in the study. Therefore, a description of these elements is not possible with the given data.

Additional relevant information about drug administration, dosing schedules, and participant compliance monitoring is also absent from the provided data. As such, no further details can be included in this description.

The clinical trial is designed to assess efficacy in a Phase 2 study. The trial is scheduled to begin recruitment on June 16, 2025, with an estimated end date of August 25, 2025. The efficacy assessment will be conducted using predefined endpoints, although specific primary and secondary endpoints are not detailed in the available data. The trial will follow a structured timeline to ensure systematic data collection and analysis. The methods and tools for measuring efficacy parameters are not specified in the provided information. The trial's focus is on evaluating the treatment's impact over the course of the study, adhering to the rigorous standards expected in clinical research.