Clinical & Medical Biochemistry

Pharmacokinetics, safety of a single dose and multiple doses of voriconazole injection, a new biosimilar, in Chinese healthy volunteers

14^th International Conference on Biosimilars and Pharma Innovations

November 09, 2022 | Webinar

Ying Wang

Hangzhou Medical College, Hangzhou, China

Posters & Accepted Abstracts: Clin Med Bio Chem

Abstract:

Background and Objective: Voriconazole is a first-line medicine for treating invasive aspergillosis. We evaluated the pharmacokinetics (PK) and safety of single/multiple doses voriconazole injection of Hailing Pharmaceutical Group (Test, T), a biosimilar to Vfend® (Refence, R). Methods: Healthy Chinese volunteers (HVs) (n=36) were divided into 1:1:1:1. HVs randomly received a once-daily dose of T or R 3- or 4-mg/kg on day 1 (single dose), a once-daily dose of T or R 6-mg/kg on day 4, then 6 consecutive days for twice-daily doses of T or R 3- or 4-mg/kg (multiple doses). The plasma concentration of voriconazole was collected up 72 hours at scheduled times after dosing on day 1 and day 10. Samples were measured by LC-MS/MS method. PK parameters were ascertained based on a noncompartmental model. Results: The PK profiles of single/multiple doses of T and R were similar in 3- or 4-mg/kg groups. Voriconazole injection of T or R were rapidly absorbed, reaching maximum plasma concentrations (Cmax) between 2.0 and 2.17h. Cmax after single dose of (3mg/kg T or R) and (4mg/kg T or R) were (1471.11±227.68ng/ml, 1443.33±449.58ng/ml) and (2150.00±340.81ng/ml, 2356.67±251.15ng/ml). Cmas at steady state (Cmax,ss) after multiple doses of (3mg/ kg T or R) and (4mg/kg T or R) were (3735.56±1465.28ng/ ml, 4792.22±2430.12ng/ml) and (6752.22±2128.90ng/ml, 6415.71±1770.92ng/ml). No serious advents events occurred. AEs were observed in 100.00% of HVs after receiving T or R formulations in both groups. Conclusions: No meaningful differences were found in safety and tolerance between T and R formulations. T formulation represents a new potential alternative medicine for patients. The trial was registered at chinadrugtrials.org.cn (NMPA202100180-01).