A Randomized, Open-Label, Two-Period, Two-Treatment, Crossover Bioequivalence Study of Pyridostigmine Bromide 180 mg Tablets versus a Prolonged-Release Reference Product in Healthy Volunteers under Fed Conditions

The primary objective of this study is to evaluate the bioequivalence of pyridostigmine bromide 180 mg prolonged-release tablets compared to the reference product in healthy volunteers under fed conditions. Establishing equivalence is clinically significant to ensure that the test formulation provides a comparable rate and extent of absorption to the innovator product for the management of myasthenia gravis. This study follows a cross-over design to assess the pharmacokinetic profile of the medicinal products.

The sponsor did not provide information regarding the total number of participants. The study population consists of healthy volunteers, including both males and females, within the age range corresponding to code 3. The population includes vulnerable individuals. The clinical focus involves the treatment of myasthenia gravis.

This open-label, randomized, single-dose, two-treatment, two-period, cross-over bioequivalence study is designed to compare pyridostigmine bromide 180 mg tablets with Mestinon® retard 180 mg prolonged-release tablets. The investigation involves healthy male and female volunteers under fed conditions. The methodology utilizes a cross-over design to assess the pharmacological equivalence of the two products. The clinical procedure includes a screening visit to evaluate eligibility, followed by specific study visits to administer the treatments and monitor outcomes. The trial is scheduled to take place between January 15, 2026, and March 20, 2026. Participant involvement is subject to the completion of the prescribed sequence of study visits, including the end-of-study visit, although early termination may occur based on established protocol criteria.

Efficacy in the treatment of myasthenia gravis will be evaluated within this Phase 2 clinical trial. The specific endpoints, assessment methods, and schedules for measuring clinical response are not defined.