摘要
目的探讨地诺孕素片在健康人群中的生物等效性。方法选取武汉市传染病医院2023年2月6日至5月9日征集的健康女性受试者61例,随机分为空腹组(30例)和餐后组(32例),受试者进行2个周期的随机开放临床试验,分别在空腹或餐后状态下口服受试制剂或参比制剂,清洗期5 d。采用高效液相色谱串联质谱法检测人血浆中地诺孕素的质量浓度。用Phoenix^(®)inNonlin^(®)软件(Pharsight^(®)Corporation,8.3版本)分别计算受试者空腹和餐后服用地诺孕素片的药物代谢动力学参数,并评估2种制剂的生物等效性和安全性。结果2种制剂的峰浓度(C_(max))、AUC_(0-t)、AUC_(0-∞)经对数转换后90%置信区间分别为,空腹状态下(90.15%,103.24%),(98.39%,104.86%),(98.50%,105.56%),餐后状态下(90.58%,102.38%),(98.59%,103.73%),(98.87%,104.31%),均在80.00%~125.00%范围内。空腹组和餐后组的不良事件发生率分别为26.67%和35.48%,未发生严重不良事件。结论该研究中地诺孕素片的受试制剂与参比制剂在健康人群中具有生物等效性。
Objective To investigate the bioequivalence of Dienogest Tablets in healthy volunteers.Methods A total of 61 healthy female volunteers admitted to Wuhan Infectious Disease Hospital from February 6 to May 9,2023 were enrolled and randomly divided into the fasted group(30 cases)and the fed group(32 cases).The participants were given two cycles of randomized open-label clinical trial,and the test formulation or reference formulation were taken orally in the fasted or fed state,with a cleaning period of 5 d.The mass concentration of dienogest in human plasma was detected using the high performance liquid chromatography-tandem mass spectrometry.The pharmacokinetic parameters of Dienogest Tablets of participants who took them in the fasted or fed state were calculated by Phoenix^(®) inNonlin^(®) software(Pharsight^(®) Corporation,version 8.3),and the bioequivalence and safety of the two formulations were evaluated.Results The peak concentration(Cmax),AUC_(0-t),and AUC_(0-∞) of the two formulations were log transformed with 90%confidence intervals as follows:in the fasted state(90.15%,103.24%),(98.39%,104.86%),(98.50%,105.56%);in the fed state(90.58%,102.38%),(98.59%,103.73%),(98.87%,104.31%),all falling within the range of 80.00%to 125.00%.The incidence of adverse events in the fasted group and the fed group was 26.67%and 35.48%,respectively,with no serious adverse events occurring.Conclusion The test formulation of Dienogest Tablets is bioequivalent to the reference formulation in healthy volunteers.
作者
王丹杰
汪洋
刘诚
王灿
朱小珊
WANG Danjie;WANG Yang;LIU Cheng;WANG Can;ZHU Xiaoshan(Wuhan Jiulong Humanwell Pharmaceutical Co.,Ltd,Wuhan,Hubei,China 430206)
出处
《中国药业》
2025年第16期73-76,共4页
China Pharmaceuticals
