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Pharmacokinetics and Safety of Ginsenoside Rd Following a Single or Multiple Intravenous Dose in Healthy Chinese Volunteers
Author(s) -
Zeng Xing,
Deng Yuanhui,
Feng Yi,
Liu Yiming,
Yang Liu,
Huang Yu,
Sun Jing,
Liang Weixiong,
Guan Yongyuan
Publication year - 2010
Publication title -
the journal of clinical pharmacology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.92
H-Index - 116
eISSN - 1552-4604
pISSN - 0091-2700
DOI - 10.1177/0091270009344334
Subject(s) - pharmacokinetics , medicine , crossover study , adverse effect , clearance , dosing , pharmacology , washout , anesthesia , urology , alternative medicine , pathology , placebo
The pharmacokinetics and safety of ginsenoside Rd (Rd) were assessed in healthy Chinese volunteers. In the single‐dose study, a randomized, open‐label, 3‐way crossover design was used. Participants were assigned to receive 10, 45, or 75 mg Rd by intravenous infusion, with a 2‐week washout period between dosing periods. Plasma levels of Rd were found to be proportional to dose, with the mean C max and AUC 0‐∞ ranging from 2.8 to 19.3 mg/L and 27.9 to 212.5 mg·h/L over the dose range studied. Ginsenoside Rd was slowly cleared from plasma (t 1/2Z = 17.7–19.3 hours). In the multiple‐dose study, 10 mg Rd was administered once daily for 6 days. Slight drug accumulation was noted. The mean steady‐state C max , AUC 0‐∞ , and AUC ss were 4.0 mg/L, 51.7 mg·h/L, and 26.4 mg·h/L, respectively. The t 1/2Z was 20.5 hours, which was similar to the single‐dose value. Ginsenoside Rd was well tolerated with no pattern of dose‐related adverse events. It had a favorable pharmacokinetic and safety profile that enables the drug to be explored in future clinical studies that target patients with acute ischemic stroke.