Pharmacokinetic and safety profiles of mesalazine enema in healthy Chinese subjects: A single- and multiple-dose study

• Published in: PloS one Vol. 19; no. 2; p. e0296940
• Main Authors: Cao, Yuran, Wang, Jingjing, Tang, Xingyu, Tian, Yan, Yu, Jicheng, Liang, Hong, Wu, Jufang, Chen, Yuancheng, Cao, Guoying, Zhang, Jing
• Format: Journal Article
• Language: English
• Published: United States Public Library of Science 02.02.2024; Public Library of Science (PLoS)
• Subjects: Administration, Oral; Analysis; Area Under Curve; Care and treatment; China; Chromatography, Liquid; Complications and side effects; Diagnosis; Dose-Response Relationship, Drug; Health aspects; Healthy Volunteers; Humans; Liquid chromatography; Mass spectrometry; Medical research; Medicine, Experimental; Mesalamine; Mesalamine - adverse effects; Metabolites; Patient outcomes; Pharmacokinetics; Respiratory tract diseases; Tandem Mass Spectrometry - methods; Ulcerative colitis; China

Mesalazine is a well-established treatment for ulcerative colitis by oral or topical administration. However, the pharmacokinetic (PK) and safety profiles of mesalazine administered by an enema has not been clarified in Chinese population. We conducted an open-label study to assess the PK and safety...