Pharmacokinetics and food impact assessment of ademetionine enteric‐coated tablet as an endogenous substance drug in healthy Chinese volunteers

餐后 医学 药代动力学 内科学 胃肠病学 不利影响 最大值 肠衣 药理学 胰岛素
作者
Jiaqi Zhang,Hanbing Liu,Liling Tang,Huaqing Lin,Yu Yao,Yao Tong,Min Kyung Jin,Keqiang Wang
出处
期刊:Journal of Clinical Pharmacy and Therapeutics [Wiley]
卷期号:47 (6): 738-744 被引量:1
标识
DOI:10.1111/jcpt.13601
摘要

What is known and objectives Ademetionine 1,4-Butanedisulfonate (SAMe) enteric-coated tablets are widely used for treatment of pre-cirrhotic and cirrhotic intrahepatic cholestasis, as well as intrahepatic cholestasis of pregnancy (ICP), but incomplete clinical data and interference from endogenous substances pose numerous challenges for clinical trial of ademetionine. The objective of this study was to evaluate the pharmacokinetic profile of SAMe enteric-coated tablets and to assess its food impact and safety in healthy Chinese subjects. Methods A randomized, open-label, single-dose study was carried out to determine the pharmacokinetics of SAMe enteric-coated tablets administered in both fasted and postprandial conditions. Baseline collection and data adjustment were required to reduce the effect of endogenous substances. Relevant pharmacokinetic data from subjects administered the reference formulation will be disclosed and utilized in this thesis. Results Twenty-four subjects with a body mass index (BMI) of 19–24 kg/m2 were enrolled in the study and all completed the trial. The impact of food on the drug was noticeable, with faster absorption in the fasting group (Tmax, 4.50 ± 1.07 and 7.50 ± 1.58 for the fasting and postprandial groups, respectively) but higher exposure in the postprandial group (AUC0–inf, 4021.02 ± 3377.13 and 5087.28 ± 3539.26 for the fasting and postprandial groups, respectively). No serious adverse effects were observed in the fasted and postprandial conditions. What is new and conclusions The pharmacokinetic profile of SAMe enteric-coated tablets in healthy Chinese subjects was partially complemented in this study. SAMe enteric-coated tablets showed promising safety in fasted and postprandial conditions. However, the impact of food on the drug was significant and might access to the absorption site and affect biochemical reactions.
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