摘要
目的:评价国产美洛昔康片与进口美洛昔康片在中国健康志愿者空腹和进食条件下的生物等效性。方法:采用开放、均衡、单剂量、双周期、随机交叉设计,分为空腹和进食2种条件。每种条件下各有28名健康志愿者随机分为2组,单剂量口服美洛昔康片受试制剂(T)或参比制剂(R)7.5 mg,验证的液相色谱-串联质谱法测定血浆中美洛昔康的浓度。血药浓度数据采用Phoenix^TM WinNonlin■软件(PharsightCorporation,6.4)进行药动学参数的计算和统计分析。安全性统计分析采用SAS 9.4版本软件进行计算分析。结果:空腹条件下,美洛昔康受试制剂与参比制剂的Cmax分别为(910.68±200.09)和(814.79±201.37)ng·mL^-1,Tmax分别为3.98[1.98,9.98]和3.98[3.48,10]h,t1/2分别为(8.23±1.12)和(21.11±5.35)h,AUC0-t分别为(4.06±1.10)和(3.91±1.05)ng·h·mL^-1;AUC0-∞分别为(4.14±1.15)和(3.98±1.10)ng·h·mL^-1。进食条件下,美洛昔康受试制剂与参比制剂的Cmax分别为(782.22±81.11)和(764.07±75.80)ng·mL^-1,Tmax分别为4.48[2.98,11.98]和4.48[2.98,12]h,t1/2分别为(22.07±7.63)和(21.76±6.40)h,AUC0-t分别为(23633.57±6679.73)和(23863.75±6051.74)ng·h·mL^-1;AUC0-∞分别为(25525.13±9076.08)和(25584.87±7676.27)ng·h·mL^-1。受试制剂与参比制剂空腹和餐后状态下的Cmax,AUC0-t,AUC0-∞的T∶R比值的90%置信区间均在80.00%~125.00%等效区间内。结论:国产美洛昔康片与进口美洛昔康片在中国健康志愿者空腹和进食条件下均具有生物等效性。
Objective:To evaluate the bioequivalence of meloxicam tablets under fasting and fed conditions in Chinese healthy volunteers.Methods:An open,balanced,single-dose,double-cycle,randomized and crossover design was adopted,28 healthy volunteers were randomly divided into two groups under each fasting and fed condition.They were administered a single dose of 7.5 mg meloxicam test tablets(T)or reference tablets(R)orally.The plasma concentrations of meloxicam were determined by a validated high performance liquid chromatography-mass spectrometry method.The pharmacokinetic parameters were calculated and statistically analyzed with PhoenixTM Winnonlinsoftware(Pharsight■Corporation,6.4).The software of SAS 9.4 was used for safety statistical analysis.Results:Under fasting condition,the Cmax of meloxicam test tablets and reference tablets were(910.68±200.09)and(814.79±201.37)ng·mL^-1;Tmax were(3.98[1.98,9.98])and(3.98[3.48,10])h;t1/2 were(21.26±5.56)and(21.11±5.35)h;AUC0-t were(25440.82±5799.43)and(24572.04±5766.93)ng·h·mL^-1;AUC0-∞were(26832.85±7099.21)and(25810.89±6796.60)ng·h·mL^-1.Under fed condition,the Cmax of meloxicam test tablets and reference tablets were(782.22±81.11)and(764.07±75.80)ng·mL^-1;Tmax were(4.48[2.98,11.98])and(4.48[2.98,12])h;t1/2 were(22.07±7.63)and(21.76±6.40)h;AUC0-t were(23633.57±6679.73)and(23863.75±6051.74)ng·h·mL^-1,respectively;AUC0-∞were(25525.13±9076.08)and(25584.87±7676.27)ng·h·mL^-1.The 90%confidence intervals of the T∶R ratios of Cmax,AUC0-t and AUC0-∞were all within the equivalent interval of 80.00%~125.00%.Conclusion:Domestic meloxicam tablets and imported meloxicam tablets are bioequivalent in Chinese healthy volunteers under fasting and fed conditions.
作者
贾元威
郭南
王萍
王亚芹
项婷
王昌茂
詹翠娇
张荣
胡容峰
沈杰
JIA Yuan-wei;GUO Nan;WANG Ping;WANG Ya-qin;XIANG Ting;WANG Chang-mao;ZHAN Cui-jiao;ZHANG Rong;HU Rong-feng;SHEN Jie(Yijishan Hospital,Wannan Medical College,Wuhu 241001,China;Pharmacy School of Wannan Medical College,Wuhu 241001,China;Jiangsu Simcere Pharmaceutical Co.,Ltd.,Nanjing 210042,China;Key Laboratory of Xin'an Medicine,Anhui University of Traditional Chinese Medicine,Hefei 230012,China)
出处
《中国新药杂志》
CAS
CSCD
北大核心
2020年第18期2118-2123,共6页
Chinese Journal of New Drugs
基金
国家自然科学基金面上项目(81973488)
皖南医学院弋矶山医院引进人才专项基金(YR201913,YR202015)
皖南医学院弋矶山医院科研能力“高峰”培育计划精英项目(201909,201910)
2019年皖医弋矶山医院管理与服务创新重点项目(201913)。