Safety assessments
All subjects included were confined for 48-72 hours after drug
administration. Recordings of adverse events, standard laboratory
parameters (hematology, biochemistry and urinalysis), physical
examination, vital signs, temperature and electronic 12 lead
electrocardiograms (ECG) measurements (Cardioperfect, Welch Allyn,
Rijswijk, The Netherlands) were performed at regular time points before
and after dosing. In addition, from 30 minutes before dosing until 12
hours after dosing a continuous 1-lead ECG recording was performed
(Nihon Kohden, Tokyo, Japan).