Clinical Drug Experience Knowledgebase

Criteria

Inclusion Criteria:

Ethnic origine: Caucasian
Weight: 55-95 kg
BMI: 19-29 kg/qm
Medical history without clinically relevant pathologies
Physical examination parameters and lung function without signs of clinically relevant pathologies
Electrocardiogram recording without signs of clinically relevant pathology, in particular QTc (Bazett) <440ms
Values for hematology, biochemistry and for coagulation tests of blood and urine within the normal range or showing no clinically relevant deviation as judged by the medical investigator (in particular normal values for ALAT, ASAT, LDH, gamma-GT, alkaline phosphatase, alpha-amylase and bilirubin)
Having given written informed consent before any study-related activities are carried out

Exclusion Criteria:

Evidence of clinically relevant pathology or disease
Any history of moderate or severe hypertension, hypotension or orthostatic hypotension
Mental handicap
Legal incapacity
Any history of clinically important emotional and/or psychiatric illness or of any clinically important neurological disorders and/or epilepsy
Chronic diarrhea or other chronic gastrointestinal disorders
Acute or chronic gastro-duodenal ulcers
Presence or history of endocrine disorders
Presence or history of gall stone disease, presence excluded by means of upper abdominal ultrasound
Known hypersensitivity to the study drug or constituent of the study drug
History of any relevant allergy, especially drug and/or food allergies
Strict vegetarian
Regular treatment with medications during three months prior to randomization
Receipt of any prescription or non-prescription medication, including multi-vitamin preparations within 14 days prior to drug administration and for the duration of the study
Use of St. John´s Wort or Ginkgo Biloba (also known as Ginkgo Bilbao) within 48 hours prior to randomization
Participation in a clinical study within 30 days prior to randomization
Donation of blood within 60 days prior to randomization
History of use of tobacco or nicotine-containing products within the past three months
Any history of alcohol abuse or drug addiction
Positive results at screen for drugs of abuse (cocaine, amphetamine/methamphetamine, tetrahydrocannbinol, opiates) or alcohol (breath test) at screening or on admission
Positive screen results for HBsAg, anti-HCV, or anti-HIV1&2
Consumption of abnormal quantities of coffee or tea (i.e. more than 5 cups per day [1 cup = 150 ml]
Any disease which in the Investigator´s opinion would exclude the subject from the study