title: Pharmacokinetics of single and multiple oral doses of arbidol in healthy Chinese volunteers.
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.
authors: Department of Pharmacy, Shengjing Hospital of China Medical University, Shenyang, China.
authors: Yaxin
authors: Y
authors: Sun
authors: Xiaojing
authors: X
authors: He
authors: Feng
authors: F
authors: Qiu
authors: Xu
authors: X
authors: Zhu
authors: Mingming
authors: M
authors: Zhao
authors: Jesse
authors: J
authors: Li-Ling
authors: Xianying
authors: X
authors: Su
authors: Limei
authors: L
authors: Zhao
mesh_terms: D000328:Adult; D000998:Antiviral Agents / Q000008:administration & dosage* / Q000097:blood / Q000493:pharmacokinetics*; D019540:Area Under Curve; D044466:Asian People; D002681:China / Q000453:epidemiology; D002851:Chromatography, High Pressure Liquid; D018592:Cross-Over Studies; D004334:Drug Administration Schedule; D016903:Drug Monitoring; D005260:Female; D006207:Half-Life; D006801:Humans; D007211:Indoles / Q000008:administration & dosage* / Q000097:blood / Q000493:pharmacokinetics*; D016014:Linear Models; D008297:Male; D008657:Metabolic Clearance Rate; D008954:Models, Biological; D014018:Tissue Distribution; D055815:Young Adult; D013440:Sulfides
chemical_list: D000998:Antiviral Agents; D007211:Indoles; C086979:umifenovir; D013440:Sulfides