Journal of Antimicrobial Chemotherapy, Vol 39, 93-97, Copyright © 1997 by The British Society for Antimicrobial Chemotherapy
R Teng, LC Dogolo, SA Willavize, HL Friedman and J Vincent
To determine the effect of the concurrent administration of Maalox and
omeprazole in the bioavailability of trovafloxacin (CP-99,219), an open,
placebo-controlled, randomized, four-way crossover study was conducted in
12 healthy male volunteers. Each received treatments of three 100 mg
trovafloxacin tablets in the morning 30 min after 30 mL of Maalox (A), 30
min after placebo (B), 2 h before 30 mL of Maalox (C) and 2 h after 40 mg
of omeprazole (D). For treatments A and C, Maalox was also given at 22.00 h
the night before the study day, 1 and 3 h after meals and at bedtime on the
study day. For B and D, placebo and omeprazole, respectively, were also
given at 22.00 h the night before the study day. After treatments A and C,
mean area under the curve (AUC) was reduced by 66% and 28% (14.2 and 30.2
mg.h/L), respectively, and mean T(1/2) declined by 33% and 31% (8.3 and 8.5
h), respectively, relative to the values after B (42.1 mg.h/L; 12.4 h). The
mean Kel- corrected relative bioavailabilities for A and C were 50% and
104%, respectively, suggesting a large reduction in the initial absorption
of trovafloxacin with A. Treatment D had no appreciable effect on mean
T(1/2) but mean AUC and Cmax were reduced by 18% and 32%, respectively,
relative to B. The mean relative bioavailability after D was 82%. We
conclude that the concurrent administration of trovafloxacin and aluminium-
and magnesium-containing antacids should be avoided but that
co-administration with omeprazole is unlikely to have a clinically
significant effect on the extent of absorption of the antibiotic.
ORIGINAL ARTICLES
Effect of Maalox and omeprazole on the bioavailability of trovafloxacin
Clinical Pharmacology, Central Research Division, Pfizer Inc., Groton, CT 06340, USA.
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