NCT07154095

A Single-Center, Randomized, Open-Label, Two-Sequence, Two-Period, Crossover Study Comparing the Pharmacokinetics and Safety of Pyridostigmine Sustained-Release and Immediate-Release Tablets Following Single and Multiple Doses in Healthy Chinese Participants

A Single-Center, Randomized, Open-Label, Two-Sequence, Two-Period, Crossover Study to Compare the Pharmacokinetics and Safety of Pyridostigmine Sustained-Release Tablets and Pyridostigmine Tablets Following Single and Multiple Doses in Healthy Chinese Participants

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: West China Second University Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This study aimed to assess the pharmacokinetic profile, safety, and tolerability of a new sustained-release pyridostigmine tablet versus the reference product. The evaluation was conducted in healthy participants following both single and multiple dosing.

Conditions

• Myasthenia Gravis
• Pharmacokinetics

Interventions

Type	Name	Description
DRUG	Sustained-Release Tablets	A single-center, randomized, open-label, two-sequence, two-period, crossover design was employed. Forty healthy participants were enrolled and randomized (1:1) into two sequences (AB and BA) to receive both the test and reference formulations across two periods, separated by a washout interval of at least 5 days.
DRUG	Immediate-Release Tablets	A single-center, randomized, open-label, two-sequence, two-period, crossover design was employed. Forty healthy participants were enrolled and randomized (1:1) into two sequences (AB and BA) to receive both the test and reference formulations across two periods, separated by a washout interval of at least 5 days.

Timeline

• Start date: 2023-08-10
• Primary completion: 2023-11-22
• Completion: 2024-02-06
• First posted: 2025-09-04
• Last updated: 2025-09-04

Locations

1 site across 1 country: China