[Difference between the effects of 2 galenically different oxazepam formulations on the EEG]

A clinical-experimental investigation was carried out in 14 healthy male test-subjects, according to a randomized double-blind cross-over design, in which the sedative and tranquillizing effects of two different oxazepam formulations were studied, with EEG examinations and psychometric tests. An adequate effect was observed with both formulations, with the same oxazepam dose. There were slight differences in the drug-EEG profiles, indicating a more rapid onset of action and a somewhat longer-lasting effect of oxazepam (Sigacalm) up to the 6th h after ingestion, in comparison with the standard form. Neither formulation leads to any psychometrically measurable loss of performance, but slight differences are observed in the increased performance induced by exercise: from the 2nd to the 6th h after ingestion it is slightly less with the trial preparation than with the standard form. Side effects were observed with neither formulation. The differences in the EEG quantification after administration o the two products are probably due to differences in the absorption and distribution of the two different galenical formulations.