Bioequivalence study of ritonavir tablets in Chinese healthy subjects
10.13699/j.cnki.1001-6821.2024.10.023
- VernacularTitle:利托那韦片在中国健康受试者中的生物等效性研究
- Author:
Yuan-Yuan XU
1
;
Chuan-Shu WANG
;
Shao-Chun CHEN
;
Jia-Xiang DING
;
Xue-Feng WANG
;
He-Yue WANG
;
Jing XIE
;
Huan ZHOU
Author Information
1. 蚌埠医科大学药学院,安徽蚌埠 233000;蚌埠医科大学第一附属医院临床试验研究中心,安徽蚌埠 233000
- Keywords:
ritonavir tablets;
bioequivalence;
pharmacokinetics
- From:
The Chinese Journal of Clinical Pharmacology
2024;40(10):1502-1506
- CountryChina
- Language:Chinese
-
Abstract:
Objective To evaluate the bioequivalence of a single oral dose of ritonavir in fasted and fed conditions in healthy Chinese adult subjects with the test and reference formulations.Methods A single-center,open-label,randomized,single-dose,two-periods,two-sequence crossover design was used,and 64 subjects were enrolled in both the fasted and fed groups.The subjects received 100 mg of the test preparation or reference preparation orally per cycle,and the drug concentration of ritonavir in plasma was detected using the high performance liquid chromatography-tandem mass spectrometry(HPLC-MS/MS)method.Pharmacokinetic parameters were estimated by a non-compartment model,and SAS 9.4 software was used for statistical analysis.Results Arithmetic mean values of the main pharmacokinetic parameters of the subject formulation of ritonavir tablets and the reference formulation in the fasting group:Cmax were(791.90±400.20)and(809.60±449.14)ng·mL-1;AUC0_t were(6 072.61±2 631.98)and(6 296.30±3 388.95)ng·h·mL-1;AUC0-∞ were(6 129.59±2 655.57)and(6 347.26±3 434.12)ng·h·mL-1,respectively.Arithmetic mean values of the main pharmacokinetic parameters of the subject formulation of ritonavir tablets and the reference formulation in the fed group:Cmax were(512.37±233.60)and(521.74±223.87)ng·mL-1;AUC0_t were(4 203.43±2 221.33)and(4 200.13±1 993.50)ng·h·mL-1;AUC0_∞ were(4 259.21±2 266.88)and(4 259.63±2 044.12)ng·h·mL-1.The 90％confidence intervals for the geometric mean ratios of Cmax,AUC0_t and AUC0_∞ of the prototype drug ritonavir in plasma after oral administration of 100 mg of the test and reference formulations of ritonavir tablets under fasting and fed conditions fell within the 80.00％to 125.00％equivalence interval.Conclusion The test and reference formulations of ritonavir tablets were bioequivalent under fasting and postprandial conditions.
