Bioequivalence study of buthlphthalide injection in Chinese healthy volunteers

Author: Mingmin CAI ¹ ; Huiping WANG ¹ ; Mingmin CAI ² ; Lu TANG ² ; Qiuyue SUN ² ; Ting DOU ² ; Wei QIAN ² ; Huiping WANG ² ; Jing SHAO ³
Author Information

1. Drug Clinical Trial Institution, Zhongda Hospital, Southeast University
2. Phase I Clinical Trial Center, Zhongda Hospital, Southeast University
3. Nanjing Yoko Pharmaceutical Co., Ltd.
Publication Type:Journal Article
Keywords: Bioequivalence; Buthlphthalide injection; HPLC-MS/MS
From: Chinese Journal of Clinical Pharmacology and Therapeutics 2022;27(1):70-76
CountryChina
Language:Chinese
Abstract: AIM: To establish a method to investigate pharmacokinetics and bioequivalence of buthlphthalide injection. METHODS: An open, randomized, and two-cycle crossover study was conducted in 24 healthy volunteers. Plasma concentrations of buthlphthalide were determined by LC-MS/MS after administering a single dose of reference drug or test drug. Main pharmacokinetic parameters were calculated by Phoenix WinNonlin 6.4 software. RESULTS: For the test drug and the reference drug, the main pharmacokinetic parameters of flurbiprofen were as follows: AUC