Pharmacokinetics and Safety of Polaprezinc Granules Oral Administration in Healthy Chinese Volunteers Under Fasting and Fed Conditions.

ABSTRACT: The study aimed to demonstrate bioequivalence between generic and original polaprezinc granules by comparing pharmacokinetic (PK) profiles in healthy Chinese subjects under fasting and fed conditions. This PK investigation was conducted with two independent, randomized, open-label, single-dose, two-period, cross-over studies. Healthy Chinese fasting (N = 24, 75 mg) or fed (N = 24, 300 mg) subjects randomly received a single oral dose of the test or reference polaprezinc granules at each period. Blood samples were collected pre- and post-dose for up to 12 h. Blood zinc was determined using a validated ICP-MS method. Primary PK endpoints were calculated using non-compartmental methods, including peak concentration (C_max) and the areas under the plasma concentration-time curve (AUC

SUBMITTER: Xiao M 

PROVIDER: S-EPMC12261970 | biostudies-literature | 2025 Jul

REPOSITORIES: biostudies-literature