Single Dose Followed by Maintenance Dose Tolerance Study of BIIR 561 CL in Healthy Elderly Male and Female Volunteers

Inclusion criteria

• Healthy male and female volunteers
• Age >= 60 years
• Broca index from -25% to +25%
• Written informed consent prior to admission to the study

Exclusion criteria

• Any finding of the medical examination (including blood pressure, pulse rate and Electrocardiogram (ECG)) deviating from normal and of clinical relevance
• Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders (exclusion: substitution therapy regarding thyroid gland and/or ovaries)
• Diseases of the central nervous system (CNS) (such as epilepsy) or psychiatric disorders or neurological disorders and medical history of such diseases or disorders
• History of orthostatic hypotension, fainting spells or blackouts
• Chronic or relevant acute infections
• Allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
• Intake of drugs with a long half-life (> 24 hours) within at least one month or less than ten half-lives of the respective drug before enrolment in the study
• Intake of any drugs which might influence the results of the trial (<= one week prior to administration or during the trial)
• Participation in another trial with an investigational drug (<= two months prior to administration or during the trial
• Smoker (> 10 cigarettes or > 3 cigars or > 3 pipes/day)
• Inability to refrain from smoking on trial days
• Alcohol abuse (> 30g/day for males, > 24 g for females)
• Drug abuse
• Blood donation (>= 100 ml within four weeks prior to administration or during the trial)
• Excessive physical activities (within the last week before the study)
• Any laboratory value outside the reference range of clinical relevance