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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
40
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.
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.
West China Second University Hospital
Chengdu, China
Tmax
Time to Reach Maximum Concentration
Time frame: Blood sampling: Within 1 hour pre-dose and 24 hours post-dose on Day 1; within 5 to 2 minutes pre-dose and 24 hours post-dose on Day 5.
Cmax
Peak Concentration
Time frame: Blood sampling: Within 1 hour pre-dose and 24 hours post-dose on Day 1; within 5 to 2 minutes pre-dose and 24 hours post-dose on Day 5.
AUC
Area under the plasma concentration-time curve
Time frame: Blood sampling: Within 1 hour pre-dose and 24 hours post-dose on Day 1; within 5 to 2 minutes pre-dose and 24 hours post-dose on Day 5.
TEAE
Treatment-emergent adverse event (TEAE): any adverse event that first appears or worsens in severity after initiation of study treatment
Time frame: From first dose of study drug up to a maximum of 6 days
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