[Pharmacodynamic bioequivalence of piracetam in hypoxic hypoxia]

An open cross-over study was run in 8 healthy, younger male volunteers (2 trial days, 7-day wash-out period). After assessment of room air and hypoxia prevalues (10.5% oxygen, inspiratory), 1600 mg 2-oxo-pyrrolidine-1-acetamide (piracetam)--using two commercial formulations (Encetrop and reference drug)--was administered and further two hypoxia tests were run. Two different methods (the oculodynamic test with evaluation of oculomotor and operational phenomena under inspiratory hypoxia and vigilance-controlled hypoxia-EEG) supported the hypotheses that piracetam revealed a hypoxia-protective effect with improvement of performance under hypoxia and a normalisation in the computer-EEG pattern, as well as the hypothesis of "pharmacodynamic bioequivalence" between the two different products, which was supported by blood kinetics and effect kinetics, too.