Profiling the Effect of Food on Drug Bioavailability

Parameter n EE + placebo Arith. CV (%) mean Geo. mean n EE + Drug XYZ Arith. CV (%) mean Geo. mean 

Pharmacodynamics Serum progesterone and 17-P-estradiol levels are considered reliable indicators for the occurrence of ovulation. Since progesterone and 17-f)-cstradiol levels were comparable for both treatments, and progesterone serum concentrations did not exceed 1.4 ng/mL (as defined in this study, progesterone concentrations above 1.4 ng/mL on day 20 of a menstrual cycle indicated ovulation) for both treatments, it was concluded that Drug XYZ administration did not affect the contraceptive effect of ethinylestradiol-based oral contraceptives and that no ovulation occurred in any of the subjects. 

The design of an exploratory food interaction bioavailability study with drug XYZ1234 is presented below. In this given project, the food interaction study was initiated parallel to a hADME study just after completion of the first-in-man study. In this study, the collection, handling, and interpretation of pharmacokinetic data were in the main focus. 

Study of the effect of food on the pharmacokinetics of film-coated tablets (3 x 200 mg) of XYZ1234 in healthy men. 

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