Bioequivalence and Pharmacokinetic Evaluation of 2 Pyrazinamide Formulations in Healthy Chinese Adults: A Single-Dose, Open-Label, Randomized-Sequence, 2×2 Crossover Study.

ABSTRACT: A single-dose, open-label, randomized-sequence, 2×2 crossover study was conducted in healthy Chinese adults, after fasting and postprandial, to evaluate the bioequivalence of 2 pyrazinamide (PZA) formulations. Fasting and postprandial tests were conducted in 24 cases. Test-reference and reference-test were randomly divided into 2 sequence groups, with 12 cases in each group. The concentration of PZA in plasma was determined after 0.5 g single oral PZA test and reference formulations by the high-performance liquid chromatography-tandem mass spectrometry method. In the fasting group, the 90% confidence intervals (CIs) of the 2 formulations maximum plasma concentration (C_max ), area under the plasma concentration-time curve (AUC) from time 0 to last detectable plasma concentration,

SUBMITTER: Wang S 

PROVIDER: S-EPMC9298828 | biostudies-literature | 2022 Apr

REPOSITORIES: biostudies-literature