Comparative bioavailability of two oral formulations of flurazepam in human subjects

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Abstract
The systemic availability of an investigational oral formulation of flurazepam was compared to that of a commercially available product whose therapeutic efficacy has been well established by usage. The experiment was designed to dissociate formula on factors from all other sources of variation including differences between subjects, sexes, sequences of administration, experimental periods, as well as sex by sequence, sex by period, and sex by formulation interactions. Systemic availability was assessed by conventional pharmacokinetic techniques.Pharmacokinetic interpretation and statistical analysis of plasma concentrations of flurazepam and its major blood metabolites namely N‐1‐hydroxyethylfurazepam and N‐1‐desalkylflurazepam as a function of time and of systemic availability indicators revealed a nearly identical biopharmaceutical behaviour for the two preparations. A significant difference could be seen in the plasma levels of N‐1‐desalkylfurazepam between male and female subjects. The results collectively indicate a very similar biopharmaceutical performance of the two oral formulations of flurazepam.