Bioequivalence Study of Minocycline Hydrochloride Capsules in A Healthy Chinese Population
10.3870/j.issn.1004-0781.2024.10.003
- VernacularTitle:盐酸米诺环素胶囊在中国健康受试者中生物等效性研究
- Author:
Xincheng FENG
1
,
2
;
Jiongxian LYU
;
Chang SU
;
Chaochao HUANG
;
Hong SUN
;
Haijiao CHENG
;
Minlu CHENG
;
Juefang DING
;
Li DING
;
Yuwen SU
Author Information
1. 南京医科大学药学院,南京 211166
2. 南京医科大学附属逸夫医院临床药理研究中心,南京 211166
- Keywords:
Minocycline;
Bioequivalence;
High performance liquid chromatography-tandem mass spectrometry(HPLC-MS/MS);
Pharmacokinetics
- From:
Herald of Medicine
2024;43(10):1545-1551
- CountryChina
- Language:Chinese
-
Abstract:
Objective To evaluate the bioequivalence of two formulations of minocycline hydrochloride capsules administered orally after fasting administration and fed administration.Methods An open-label,randomized,two-period,self-crossover design was employed to assess the bioequivalence study.Twenty-eight healthy subjects were enrolled in both fasting and fed groups,with each period involving a single administration of either the reference formulation or the test formulation of 50 mg,separated by a washout period of 7 days.The concentration of minocycline in human plasma was determined by HPLC-MS/MS and was used for calculating pharmacokinetic parameters and evaluating the bioequivalence of the test formulation and reference formulation.Results After oral administration of test and reference formulations of minocycline under fasting condition,the Cmax Values of minocycline were(541±137)ng·mL-1 for the test formulation and(558±140)ng·mL-1for the reference formulation.The AUC0-t values were(8 347±1 986)h·ng·mL-1 for the test and(8 205±1 790)h·ng·mL-1 for the reference.The t1/2 values were(18.2±2.84)h for the test and(18.0±3.05)h for the reference.After oral administration of the test and reference formulations of minocycline under fed condition,the Cmax values of minocycline were(349±72.1)ng·mL-1 for the test and(352±73.2)ng·mL-1for the reference.The AUC0-twere(6 428±1 077)h·ng·mL-1 for the test and(6 588±1 118)h·ng·mL-1 for the reference.The t1/2values were(18.5±3.10)h for the test and(18.4±3.21)h for the reference.Under fasting condition,the 90% confidence intervals for the geometric mean ratios of Cmax,AUC0-t,and AUC0-∞ between the test and reference formulations were(90.84%,101.46% ),(95.2%,102.8% ),and(95.31%,102.71% ),respectively.Under fed conditions,the 90% confidence intervals for the geometric mean ratios of Cmax,AUC0-t,and AUC0-∞ between the test formulation and the reference formulation were(94.71%,103.42% ),(95.40%,99.83% ),and(95.79%,100.02% ),respectively.Conclusions Bioequivalence of the two minocycline formulations was demonstrated after fasting administration and fed administration in a healthy Chinese population.
