Effect of Food on the Single-Dose Pharmacokinetics and Safety of Ulipristal Acetate in Healthy Chinese Subjects

被引：0

作者：

Wang, Yilin ^{[1
]}

Li, Yanru ^{[1
]}

Peng, Chun ^{[1
]}

Tang, Ling ^{[1
]}

Wang, Yan ^{[1
]}

机构：

[1] Dali Univ, Coll Pharm, Dali 671000, Peoples R China

来源：

LATIN AMERICAN JOURNAL OF PHARMACY | 2021年 / 40卷 / 03期

基金：

中国国家自然科学基金;

关键词：

healthy Chinese subjects; pharmacokinetics; safety; ulipristal acetate;

D O I：

暂无

中图分类号：

R9 [药学];

学科分类号：

1007 ;

摘要：

The primary objective of this study was to compare the pharmacokinetic profiles of ulipristal acetate in healthy Chinese female subjects under fasting and fed conditions after single oral dose administration of ulipristal acetate (ella (R)). Drug tolerability was also assessed. A sensitive and high-throughput LC-MS/MS method was developed to conduct the clinical trial. Eighteen subjects were enrolled in this randomized, single-center and open-label study. Co-administration of oral ulipristal acetate at 30 mg with a high-fat meal resulted in a C-max approximately 57% lower than with the fasting state. Despite the difference in C-max, no change was made in efficacy of analyte. Ulipristal acetate was safe and well tolerated. Based on the pharmacokinetics comparison of different races, the exposures of ulipristal acetate were higher in Chinese than in Caucasian volunteers.

引用

页码：542 / 545

页数：4

共 12 条

[1]

[Anonymous], 2018, Guidance for Industry: Bioanalytical Method Validation

[2]

Burroughs VJ, 2002, J NATL MED ASSOC, V94, P1

[3] Ulipristal acetate does not impact human normal breast tissue [J].