Oral bioavailability of gatifloxacin in healthy volunteers under fasting and fed conditions.
The effect of food on the pharmacokinetics of gatifloxacin given as a single oral dose of 400 mg under fasting and fed conditions was determined in 18 healthy male volunteers in an open, two-way, randomised cross-over study. Concomitant food intake did not significantly alter the peak plasma concentrations (C(max)) or the area under the plasma concentration-time curve (AUC) of gatifloxacin. The mean C(max) levels under fasting and fed conditions were 3.5 and 3.2 mg/l, respectively, after the 400-mg single dose of gatifloxacin. The corresponding mean AUC data were 32.8 mg x h/l (fasted) and 30.5 mg x h/l (fed). Moreover, the rate of absorption was not affected by food intake. The median T(max) value was 2 h in both treatment periods. No clinically relevant adverse effects or changes in clinical laboratory test results, ECGs or physical examinations were observed. The results of this study indicate that gatifloxacin given as a single 400-mg oral dose was well tolerated in the presence or absence of food. Concomitant administration of a continental breakfast with a caloric content of 1,050 kcal had no effect on the bioavailability of gatifloxacin. It is suggested that gatifloxacin can be given without regard to meals.
Mignot
Alain
A
Aster/Cephac, Paris, France.
Guillaume
Michel
M
Göhler
Karin
K
Stahlberg
Hans-Jürgen
HJ
D000284:Administration, Oral; D000328:Adult; D000890:Anti-Infective Agents / Q000008:administration & dosage / Q000493:pharmacokinetics*; D001682:Biological Availability; D004435:Eating; D005215:Fasting; D024841:Fluoroquinolones; D000077734:Gatifloxacin; D006801:Humans; D008297:Male
D000890:Anti-Infective Agents; D024841:Fluoroquinolones; D000077734:Gatifloxacin