[Safety and tolerance study of single oral dose of adefovir dipivoxil tablets in healthy volunteers].
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.
Wang
Hai-sheng
HS
Department of Pharmacy, Second Hospital of Shandong University, Jinan 250033, China.
Sun
De-qing
DQ
Fan
Xiao-peng
XP
Wang
Ben-jie
BJ
Wang
Kai
K
Guo
Rui-chen
RC
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
D000998:Antiviral Agents; D063065:Organophosphonates; D013607:Tablets; D000225:Adenine; C106812:adefovir dipivoxil