F. Abadsantos et al., EVALUATION OF SEX-DIFFERENCES IN THE PHARMACOKINETICS OF RANITIDINE IN HUMANS, Journal of clinical pharmacology, 36(8), 1996, pp. 748-751
A bioequivalence study of two oral formulations of 300 mg ranitidine w
as carried out in 16 healthy volunteers (8 men and 8 women), and the p
harmacokinetics in both sexes were compared. There was bioequivalence
of both formulations. The terminal half-life of ranitidine was 7% shor
ter and the oral apparent clearance 10.5% higher in women (1.44 L/h/kg
) than in men (1.29 L/h/kg), although this difference did not reach st
atistical significance. No differences were observed in maximum concen
tration (C-max) or the time of its occurrence (t(max)). Sex, age, and
weight did not correlate significantly with oral clearance. These resu
lts suggest that there are no sex differences in the pharmacokinetics
of ranitidine, or that any differences would not be of clinical releva
nce, It also should be emphasized that bioequivalence trials also can
be used to study other pharmacokinetic or pharmacodynamic characterist
ics of drugs without damaging the main endpoint of the study.