A Randomized, Open-Label, Two-Period, Two-Treatment, Cross-Over Bioequivalence Study of Pyridostigmine Bromide 180 mg Tablets versus Prolonged-Release Pyridostigmine Bromide in Healthy Volunteers

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 fasting conditions. Establishing bioequivalence is clinically essential to ensure that the test product maintains equivalent pharmacokinetic profiles to the reference medication used in the treatment of myasthenia gravis.

The sponsor did not provide information regarding the total number of participants. The study population consists of healthy volunteers within the age range of 1 to 12 years. The cohort includes both male and female subjects and is classified as a vulnerable population. The clinical focus involves the treatment of myasthenia gravis.

This open-label, randomized, two-period, two-treatment, cross-over bioequivalence study is designed to compare pyridostigmine bromide 180 mg tablets with Mestinon® retard 180 mg prolonged-release tablets. The investigation will be conducted in healthy male and female volunteers under fasting conditions. The research methodology involves a sequence of study visits, commencing with a screening visit to assess eligibility. Participants will undergo two distinct treatment periods to evaluate the pharmacokinetic equivalence of the products. The study includes follow-up visits and an end-of-study visit to monitor all necessary parameters. The estimated duration of the study spans from December 2025 to February 2026. Early termination of participation may occur based on predefined clinical criteria or protocol deviations.

The assessment of efficacy in this phase 2 clinical trial for the treatment of myasthenia gravis focuses on evaluating therapeutic response. Specific parameters, measurement methods, and schedules for evaluating efficacy were not defined in the provided documentation.