Pharmacokinetics and bioequivalence of two pomalidomide capsules in healthy chinese subjects under fasting and fed conditions

Abstract

Objective: Imnovid® is an immunomodulatory drug with antineoplastic activity. The aim of this study was to evaluate the bioequivalence and safety of the generic drug pomalidomide (Chia Tai Tianqing Pharmaceutical Group Co., Ltd) and its originator product Imnovid® (Celgene Europe Ltd) in the fasting and fed states, respectively.

Methods: The research consisted of two parts: one with a dose of 1 mg and the other with a dose of 4 mg. 48 healthy subjects were included in each study and were divided into two groups (fasting group and fed group) at a 1:1 ratio to administrate study drugs orally. The plasma drug concentrations were determined by liquid chromatography-tandem mass spectrometry (LC-MS/MS).

Results: The 90% CI of GMR for main pharmacokinetic (PK) parameters (C_max, AUC_{0 - t} and AUC_0-∞) met the requirements of bioequivalence standards. The incidence and severity of AEs associated with pomalidomide and Imnovid® were similar.

Conclusion: The results proved the PK parameters of pomalidomide and Imnovid® were similar and bioequivalent. Both drugs showed safety profile well.

Keywords: Bioequivalence; Multiple myeloma; Pharmacokinetics; Pomalidomide; Safety.