Bioequivalence study of dienogest tablets in Chinese healthy adult female subjects in fasting state
Suo Wei
Jing Shan
Liu Wenfang
Lu Chunyan
Yang Kexu
Liu Jingyi
Tan Li
Lin Yang
Abstract：Objective To evaluate the bioequivalence and safety of dienogest tablets in Chinese healthy adult female subjects in fasting state.Methods A single center,randomized,open,two-period,double crossover trial design was designed.A total of 24 Chinese healthy adult female subjects were enrolled from February 21 to March 3,2022 in Beijing Anzhen Hospital,Capital Medical University.They were divided into two groups(refer-ence preparation-test preparation group and test preparation-reference preparation group)by random number table method,with 12 people in each group.The two groups took the reference formulation and the test formulation,or the test formulation and the reference formulation(2 mg of denogestrel tablets)in fasting state on the 1st and 8th day,respectively.By collecting biological samples and analyzing the blood drug concentration,the pharmacokinetic parameters of the two drugs were compared,and the bioequivalence was evaluated.At the same time,the clinical safety of the subjects was observed.Results The pharmacokinetic parameters of fasting oral test preparation and reference preparation:the peak plasma concentrations were(52±13)and(54±11)µg/L,respectively,the time to peak concentrations were 1.75(0.50,5.50)and 1.00(0.50,5.50)h,respectively,area under the curve of the blood drug concentration-time from 0 to t were(620±87)and(604±99)h·μg/L,respectively,the area under the curve of the blood drug concentration-time from 0 to infinity were(644±97)and(628±111)h·μg/L,respectively,and the plasma elimination half-life were(9.7±1.5)and(9.8±1.8)h,respectively.The geometric mean ratios of the main pharmacokinetic parameters were within the bioequivalent range of 80％to 125％.During the study period,there were no adverse events leading subjects withdrawal or serious adverse events in both groups.Conclusion The test preparation and reference preparation of dienogest tablets are bioequivalent and have high safety in Chinese healthy adult female subjects under fasting state.
Keywords：DienogestBioequivalenceFastingSafetyPharmacokinetics
Publication Date：2024-12-08
Online Publishing Date：2026-09-14(First online date of this platform, not the publication date of the document)
Pages：4( 1831-1834 )