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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 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-09-04

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • West China Second University Hospital

    lead OTHER

Principal Investigators

  • Yu Qin · China West China Second University Hospital Chengdu, China

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

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

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07154095 on ClinicalTrials.gov