Abstract
A phase I multiple dose studies of azithromycin (AZM) was carried out in healthy male volunteers to evaluate safety and pharmacokinetics.
No appreciable change was observed in the pharmacokinetics of AZM during repeated oral dosing.
Safety was assessed by physical examinations, including ophthalmological and hearing acuity tests performed prior to and after administration. No clinically significant changes were observed in any of the safety parameters. There were no side: effects, other than mild to moderate headache, abdominal pain, upper abdomen pressure sensation, loose stools and diarrhea, observed in two patients and there were no abnormal laboratory findings attributable to azithromycin.
We conclude that AZM was generally well tolerated, and there were no clinically significant adverse effects.
Azithromycin is potentially useful antimicrobial agent which merits further clinical study.
