Phase I safety and pharmacokinetic study of magnesium isoglycyrrhizinate after single and multiple intravenous doses in Chinese healthy volunteers

作者：Sun, Li; Shen, Jinfang^*; Pang, Xiaoyun; Lu, Lungen; Mao, Yimin; Zeng, Minde

来源：The Journal of Clinical Pharmacology, 2007, 47(6): 767-773.

DOI：10.1177/0091270007299757

• safety
• pharmacokinetics
• magnesium isoglycyrrhizinate
• single dose
• multiple dose

The safety and pharmacokinetics of magnesium isoglycyrrhizinate were assessed in healthy Chinese volunteers. In the single-dose format of this pharmacokinetic study, 100-, 200-, and 300-mg doses of magnesium isoglycyrrhizinate were given by intravenous infusion. The results indicated that the plasma levels were directly proportional to the administered dose, with the mean Cm and AUC(0-72) ranging from approximately 28.79 to 99.28 mg center dot L-1 and 448.68 to 1688.42 mg center dot h center dot L-1 over the dose range. In the multiple-dose format of this pharmacokinetic study, 100 mg magnesium isoglycyrrhizinate was administrated once daily for 9 days. Moderate drug accumulation was noted, which was attributable to the drug's long terminal half-life of 19 to 31 hours. The distribution and elimination rate of magnesium isoglycyrrhizinate had no changes. It had a favorable pharmacokinetics and safety profile that enables the drug to be explored in future clinical studies that target patients with hepatic impairment.

• 出版日期2007-6
• 单位上海交通大学