title: Phase I safety and pharmacokinetic study of magnesium isoglycyrrhizinate after single and multiple intravenous doses in chinese healthy volunteers.
abstract: 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 C(max) and AUC(0-72) ranging from approximately 28.79 to 99.28 mg x L(-1) and 448.68 to 1688.42 mg x h x 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.
authors.affiliation: Department of Clinical Pharmacology, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, 145 Middle Shan-dong Road, Shanghai, 200001 China.
authors.forename: Li
authors.initials: L
authors.lastname: Sun
authors.forename: Jinfang
authors.initials: J
authors.lastname: Shen
authors.forename: Xiaoyun
authors.initials: X
authors.lastname: Pang
authors.forename: Lungen
authors.initials: L
authors.lastname: Lu
authors.forename: Yimin
authors.initials: Y
authors.lastname: Mao
authors.forename: Minde
authors.initials: M
authors.lastname: Zeng
mesh_terms: D000328:Adult; D019540:Area Under Curve; D044466:Asian People; D002681:China; D002851:Chromatography, High Pressure Liquid; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D005260:Female; D006207:Half-Life; D006801:Humans; D008297:Male; D008657:Metabolic Clearance Rate; D012503:Saponins / Q000009:adverse effects* / Q000493:pharmacokinetics*; D014315:Triterpenes / Q000009:adverse effects* / Q000493:pharmacokinetics*
chemical_list: C521270:18alpha,20beta-hydroxy-11-oxo-norolean-12-en-3beta-yl-2-O-beta-D-glucopyranurosyl-alpha-D-glucopyranosiduronate magnesium tetrahydrate; D012503:Saponins; D014315:Triterpenes