Drug-food interaction potential of clarithromycin, a new macrolide antimicrobial.
To evaluate the effect of food on bioavailability, clarithromycin and 14-hydroxyclarithromycin (active metabolite) pharmacokinetics were assessed in 26 healthy adult volunteers after ingestion of a single oral 500-mg dose of clarithromycin in a fasting state (2 hours before breakfast after an overnight fast) and a nonfasting state (0.5 hours after the start of breakfast). Clarithromycin and 14-hydroxy metabolite plasma concentrations were measured using a high-performance liquid chromatographic technique. Food intake immediately before dosing increased the extent of absorption from the 500-mg tablet formulation by approximately 25%. The mean increase in metabolite area under the plasma concentration-time curve was approximately 9%. These results suggest that clarithromycin can be taken without regard to timing in relation to meals.
Chu
S
S
Drug Metabolism Department, Abbott Laboratories, Abbott Park, Illinois 60064-3500.
Park
Y
Y
Locke
C
C
Wilson
D S
DS
Cavanaugh
J C
JC
D000042:Absorption; D000284:Administration, Oral; D000328:Adult; D001682:Biological Availability; D002851:Chromatography, High Pressure Liquid; D017291:Clarithromycin / Q000031:analogs & derivatives; D004917:Erythromycin / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000097:blood / Q000493:pharmacokinetics; D005215:Fasting / Q000097:blood; D005502:Food; D006801:Humans; D008297:Male
C056228:14-hydroxyclarithromycin; D004917:Erythromycin; D017291:Clarithromycin