Bioequivalence Study of Pyridostigmine Bromide P.R. Tab 180 mg vs. Mestinon Retard 180 mg in Myasthenia Gravis Treatment Under Fasting Conditions

The primary objective of this study is to evaluate the **bioequivalence** of Pyridostigmine Bromide, P.R. Tab, 180 mg, produced by VIANEX S.A., Greece, compared to Mestinon® retard 180 mg, a prolonged-release tablet by Viatris Healthcare GmbH, Germany. This evaluation is conducted in healthy male and female volunteers under fasting conditions. The clinical relevance of this study lies in its potential to confirm that the two formulations of Pyridostigmine Bromide are interchangeable, which is crucial for the treatment of **myasthenia gravis**. Ensuring bioequivalence can provide more options for patients and healthcare providers, potentially improving accessibility and treatment outcomes.

The clinical trial focuses on the **treatment of myasthenia gravis** and includes both male and female participants. The study population encompasses individuals within the age range category of 3, which typically corresponds to adults aged 18 to 64 years. Participants are selected from a vulnerable population, indicating that special considerations are taken into account to ensure their safety and well-being. The sponsor has not provided information regarding the total number of participants involved in the trial. Lifestyle factors such as diet, physical activity, and habits have not been specified. The trial population was selected based on criteria that have not been disclosed by the sponsor.

The clinical trial is designed as an **open-label**, randomized, single-dose, two-treatment, two-period, cross-over pilot bioequivalence study. It aims to compare Pyridostigmine Bromide, P.R. Tab, 180 mg/tab, with Mestinon® retard 180 mg/prolonged-release tablet in healthy male and female volunteers under fasting conditions. The study is focused on the **treatment of myasthenia gravis**. The trial is categorized under Phase 2 and is expected to commence recruitment on May 8, 2025, with an estimated completion date of June 6, 2025.

Participants will undergo a sequence of study visits, beginning with an inclusion visit where eligibility is assessed. This screening visit will ensure that participants meet the necessary criteria for inclusion in the study. Following randomization, participants will receive the study treatments in two separate periods, with a washout phase in between to prevent carryover effects. Each treatment period will involve administration of a single dose of the investigational product, followed by a series of assessments to evaluate bioequivalence.

Follow-up visits will be scheduled to monitor the participants' health and collect data on the pharmacokinetic parameters of the drugs. The end-of-study visit will conclude the trial, where final assessments will be conducted to ensure participant safety and gather comprehensive data for analysis. The expected length of participant involvement is approximately one month, considering the time required for screening, treatment periods, and follow-up assessments.

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 study is structured to maintain scientific rigor and ensure the reliability of the results, contributing valuable data to the understanding of bioequivalence in the context of myasthenia gravis treatment.

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 is scheduled to commence recruitment on May 8, 2025, with an estimated completion date of June 6, 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 protocol to ensure the collection and analysis of efficacy data, adhering to the standards expected in clinical research. The trial's design and execution will be aligned with regulatory requirements to ensure the reliability and validity of the efficacy outcomes.