title: [Safety and tolerance study of single oral dose of adefovir dipivoxil tablets in healthy volunteers].
abstract: BACKGROUND
  To assess the safety and tolerance of adefovir dipivoxil tablet in Chinese healthy volunteers.
  
  
  METHODS
  Totally 42 healthy volunteers were enrolled in the study, 21 were female and 21 were male and their age ranged from 19 to 26 years. The subjects were randomly divided into 5, 10, 20, 40 and 60 mg dose-groups (6-10 subjects in each group) based on sex and weight, beginning with the 5 mg dose-group. Clinical symptoms, vital signs, electrocardiogram, routine blood test, routine urine test, prothrombin time and blood biochemical tests were recorded and evaluated.
  
  
  RESULTS
  No significant changes were found in clinical symptoms, vital signs and laboratory tests after dosing, except slight elevations of alanine aminotransferase in 2 subjects and bilirubin in 6 subjects observed and some gastrointestinal symptoms such as nausea and diarrhea found in 3 subjects, but the frequency and severity of all the adverse reactions were not found to be related to the dosages.
  
  
  CONCLUSIONS
  The results showed that single oral dose of adefovir dipivoxil 60 mg or less was safe and tolerable.
authors.affiliation: Department of Pharmacy, Second Hospital of Shandong University, Jinan 250033, China.
authors.forename: Hai-sheng
authors.initials: HS
authors.lastname: Wang
authors.forename: De-qing
authors.initials: DQ
authors.lastname: Sun
authors.forename: Xiao-peng
authors.initials: XP
authors.lastname: Fan
authors.forename: Ben-jie
authors.initials: BJ
authors.lastname: Wang
authors.forename: Kai
authors.initials: K
authors.lastname: Wang
authors.forename: Rui-chen
authors.initials: RC
authors.lastname: Guo
mesh_terms: D000225:Adenine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D000284:Administration, Oral; D000328:Adult; D000998:Antiviral Agents / Q000008:administration & dosage* / Q000009:adverse effects; D003967:Diarrhea / Q000139:chemically induced; D004305:Dose-Response Relationship, Drug; D005260:Female; D006801:Humans; D008297:Male; D009325:Nausea / Q000139:chemically induced; D063065:Organophosphonates / Q000008:administration & dosage* / Q000009:adverse effects; D013607:Tablets; D055815:Young Adult
chemical_list: D000998:Antiviral Agents; D063065:Organophosphonates; D013607:Tablets; D000225:Adenine; C106812:adefovir dipivoxil