Bioequivalence evaluation of dexamethasone palmitate injections by intravenous injection in healthy Chinese volunteers: A 2-period crossover trial

Abstract

Dexamethasone palmitate injection is mainly used in the treatment of severe rheumatoid arthritis.This study aimed to compare the bioequivalence and safety profiles of two (1 mL,:4 mg) dexamethasone palmitate injections in the fasting arm for healthy Chinese volunteers. A random, open, single-dose, two-preparations, two-sequences, two-period crossover design was conducted. Twenty-four healthy volunteers participated in the study. Each participant received an intravenous injection of either the test (imitation) or reference (original) formulation of dexamethasone palmitate in the fasting arm during each study period, with a 7-day washout period between administrations. The results showed that, under fasting condition, the pharmacokinetic parameters of the test and reference formulations were within the acceptable limits for bioequivalence. The 90% confidence intervals for the ratios of C_max and AUC_0 − t and AUC_0−∞ fell within the bioequivalence range of 80–125%, achieving 100% power. No serious adverse events were observed, and no participants withdrew from the study. All safety parameters remained within normal limits throughout the study. The imitation preparation of dexamethasone palmitate injections is bioequivalent to the original formulation when administered as a single intravenous injection under fasting condition to healthy Chinese volunteers. This finding supports the interchangeability of the imitation and original formulations, potentially offering a cost-effective alternative in clinical practice. This study was registered in the Chinese Clinical Trial Registry (registration number: CTR20211598; date of registration: July 13, 2021).