drugset / Trial / 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

NCT07154095

Phase 1 Completed 40 enrolled West China Second University Hospital
RandomizedCrossoverOpen-labelOther

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.

Timeline

Start
2023-08-10
Primary completion
2023-11-22
Completion
2024-02-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Pyridostigmine Small molecule

Indications