Open‑label, randomized, two‑period crossover bioequivalence study of pyridostigmine bromide 180 mg prolonged‑release tablet versus reference product in healthy volunteers (myasthenia gravis therapy)

Primary objective: to determine whether the test pyridostigmine bromide tablet (180 mg) is bioequivalent to the reference Mestinon® retard tablet (180 mg) in healthy adult volunteers under fasting conditions, as assessed by the rate and extent of absorption (Cmax, AUC0‑t, AUC0‑∞). Demonstrating bioequivalence supports the interchangeable clinical use of the test product for the treatment of myasthenia gravis.

Secondary objectives: • to evaluate the safety and tolerability of both formulations through adverse event monitoring, clinical laboratory assessments, and vital sign measurements; • to characterize additional pharmacokinetic parameters such as tmax, half‑life, and clearance to confirm comparable disposition profiles.

The trial population comprised both female and male participants, including individuals classified as vulnerable, who were recruited as healthy volunteers. The sponsor did not provide the total number of enrolled subjects, and specific age range data were not disclosed. Selection was based on general health status without reported requirements regarding diet, physical activity, or other lifestyle habits. Key inclusion criteria emphasized the absence of the target disease, while exclusion criteria were not detailed in the provided information.

The study is a Phase 2, open‑label, randomized, multiple‑dose, two‑treatment, two‑period cross‑over trial designed to assess bioequivalence of Pyridostigmine Bromide 180 mg tablets versus Mestinon® retard 180 mg tablets in healthy volunteers under fasting conditions. After an initial screening visit to confirm eligibility, participants receive the first investigational product for a defined dosing period, followed by a washout interval, and then cross over to the alternate product for a second dosing period. Follow‑up visits occur at the end of each dosing period to collect pharmacokinetic samples, safety assessments, and tolerability data. The final end‑of‑study visit includes a comprehensive safety evaluation and study completion procedures. Individual involvement spans approximately 4–6 weeks, encompassing screening, two treatment periods, washout, and final assessments. Early termination may occur due to significant adverse events, protocol non‑compliance, or voluntary withdrawal. The overall recruitment window is projected from 15 June 2026 to 28 August 2026, aligning with the study’s planned duration.