NDLI: Pharmacokinetics of single and multiple oral doses of arbidol in healthy Chinese volunteers.

Content Provider	World Health Organization (WHO)-Global Index Medicus
Author	Sun, Yaxin He, Xiaojing Qiu, Feng Zhu, Xu Zhao, Mingming Li-Ling, Jesse Su, Xianying Zhao, Limei
Spatial Coverage	China
Description	Country affiliation: China Author Affiliation: Sun Y ( Department of Pharmacy, Shengjing Hospital of China Medical University, Shenyang, China.)
Abstract	BACKGROUND: Arbidol is licensed in Russia and China for prophylaxis and treatment of influenza A and B. This study was to assess the pharmacokinetics of single and multiple doses of arbidol in healthy Chinese volunteers. METHODS: This was a single-center, open-label, two-phase study conducted in 12 subjects. In single-dose phase, subjects were randomized to receive single doses of 0.2, 0.4 and 0.8 g of arbidol in a crossover design with a 7-day washout period between administration. In the multiple-dose phase, subjects received 0.2 g 3 times a day for 7 days. Serial blood samples were collected at predefined time points. Plasma concentrations were determined with a validated HPLC method. Safety assessments were conducted throughout the study. RESULTS: After administration of single doses of 0.2, 0.4 and 0.8 g, geometric mean estimates for arbidol Cmax were 0.70, 1.24, and 2.16 mg/l and the mean of AUClast were 3.27, 5.81 and 12.72 mg×h/l, respectively. The AUClast and Cmax showed dose proportionality. After administration of multiple doses, the mean of Cmax,ss of arbidol was 0.41 mg/l and the mean accumulation ratio is ~ 1.12. Compared with single-dose phase, arbidol exhibited lower Cmax and prolonged plasma concentration profiles. CONCLUSIONS: In healthy Chinese subjects, single dosing of arbidol resulted in linear plasma pharmacokinetics. Arbidol exhibited little accumulation with repeated administration. Compared with single doses, multiple oral doses showed somewhat different pharmacokinetics and tissue distribution patterns. Sex did not appear to affect the pharmacokinetic properties of arbidol.
File Format	HTM / HTML
ISSN	09461965
Issue Number	5
Volume Number	51
Journal	Int. Journal of Clinical Pharmacology and Therapeutics
Language	English
Publisher	Dustri-Verlag
Publisher Date	2013-05-01
Publisher Place	Germany
Access Restriction	Subscribed
Subject Keyword	Discipline Pharmacology Antiviral Agents Administration & Dosage Pharmacokinetics Indoles Adult Blood Area Under Curve Asian Continental Ancestry Group China Epidemiology Chromatography, High Pressure Liquid Cross-over Studies Drug Administration Schedule Drug Monitoring Female Half-life Humans Linear Models Male Metabolic Clearance Rate Models, Biological Tissue Distribution Young Adult Comparative Study Journal Article Randomized Controlled Trial Research Support, Non-u.s. Gov't
Content Type	Text
Resource Type	Article
Subject	Pharmacology Pharmacology (medical)

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