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

PHASE1CompletedINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

August 10, 2023

Primary Completion Date

November 22, 2023

Study Completion Date

February 6, 2024

Conditions
Myasthenia GravisPharmacokinetics
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.

Trial Locations (1)

Unknown

West China Second University Hospital, Chengdu

All Listed Sponsors
lead

West China Second University Hospital

OTHER