Pharmacokinetics and Safety of Ginsenoside Rd Following a Single or Multiple Intravenous Dose in Healthy Chinese Volunteers

Journal of Clinical Pharmacology - Tập 50 Số 3 - Trang 285-292 - 2010
Xing Zeng1, Deng Yuanhui2, Yi Feng2, Yiming Liu2, Liu Yang2, Yu Huang2, Jing Sun2, Wei‐Xiong Liang2, Guan Yong-yuan3
1Central Laboratory, Guangdong Provincial Hospital of Traditional Chinese Medicine, Guangzhou University of Chinese Medicine, and Guangdong Provincial Academy of Chinese Medical Sciences, Guangzhou, China.
2Central Laboratory, Guangdong Provincial Hospital of Traditional Chinese Medicine, Guangzhou University of Chinese Medicine, and Guangdong Provincial Academy of Chinese Medical Sciences, Guangzhou
3Department of Pharmacology, Zhongshan School of Medicine, Sun Yat-Sen University, Guangzhou

Tóm tắt

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 Cmaxand AUC0‐∞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 (t1/2Z= 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 Cmax, AUC0‐∞, and AUCsswere 4.0 mg/L, 51.7 mg·h/L, and 26.4 mg·h/L, respectively. The t1/2Zwas 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.

Từ khóa


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Thông tin
Thông tin xuất bản

Journal of Clinical Pharmacology

Tập 50 Số 3

285-292

Thông tin tác giả