A Study on the Pharmacokinetic/Pharmacodynamic Profiles of the Novel PPAR Pan‐Agonist Chiglitazar Sodium in Rats With Hypoalbuminemia

Objective To compare the pharmacokinetic and pharmacodynamic (PK/PD) profiles after a single dose of chiglitazar sodium in healthy rats and the rats with hypoalbuminemia. Method Single doses of 3.33 mg/kg chiglitazar sodium were administered by gavage in all rats. Serial blood samples were collected for the determination of plasma concentrations of chiglitazar sodium by liquid chromatography‐tandem mass spectrometry (LC‐MS/MS) and blood concentrations of glucose by glucometer. The PK parameters were derived based on the measured plasma concentration data. Both PK parameters and the blood glucose levels were summarized and statistically compared between healthy rats and the rats with hypoalbuminemia. Results The PK analysis revealed that, compared to healthy rats, only T max in the rats with hypoalbuminemia was significantly earlier by 34.3% ( p < 0.001), while other PK parameters showed no significant differences. The PD analysis indicated that blood glucose levels remained stable in both healthy rats and rats with hypoalbuminemia during the 0.25–10‐hour monitoring period. Conclusion There were no significant differences in the PK/PD parameters between healthy rats and rats with hypoalbuminemia, except for T max . Blood glucose levels remained stable in the two groups of rats after a single oral dose of 3.3 mg/kg of chiglitazar sodium. The experimental results in rats suggest that, under normal conditions, hypoalbuminemia does not alter the PK and PD profiles of chiglitazar sodium.