[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.
D000328:Adult; D004569:Electroencephalography; D004585:Electrooculography; D006801:Humans; D000860:Hypoxia / Q000503:physiopathology*; D007700:Kinetics; D008297:Male; D010889:Piracetam / Q000494:pharmacology*; D011760:Pyrrolidinones / Q000494:pharmacology*; D013810:Therapeutic Equivalency; D013997:Time Factors
D011760:Pyrrolidinones; D010889:Piracetam
Pharmakodynamische Bioäquivalenz von Piracetam unter hypoxischer Hypoxie.