- Prior to admission to the treatment after giving his/her informed consent (in accordance with Good Clinical Practice (GCP) and local legislation) in writing each subject will have his medical history taken and will receive a complete medical examination (incl. blood pressure and pulse rate measurements) as well as a 12-lead ECG within 14 days before the administration of the test substance. Hematopoietic, hepatic and renal function test will be carried out in the laboratory. The subjects will fast for 12 hours before collection of specimens for all laboratory evaluations