Why the study?
Do the pharmacokinetics of oral fleroxacin differ between male and premenopausal female volunteers?
Do the pharmacokinetics of oral fleroxacin differ between male and premenopausal female volunteers?
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The total volume of distribution of oral fleroxacin is significantly smaller in premenopausal women compared to men, suggesting that sex-specific dose-response studies may be appropriate given higher adverse event rates in women.
The pharmacokinetics of oral fleroxacin were compared in men and premenopausal women. The total volume of distribution of the drug was significantly smaller in women in the single-dose trial. No difference in other pharmacokinetic parameters was noted. Since adverse events appear to occur in women more commonly than in men, dose-response studies of fleroxacin in women may be appropriate.
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Bertino et al. (1996) studied this question.
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