Status:
COMPLETED
Single Dose Followed by Maintenance Dose Tolerance Study of BIIR 561 CL in Healthy Elderly Male and Female Volunteers
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Healthy
Eligibility:
All Genders
60+ years
Phase:
PHASE1
Brief Summary
The objective of the present study was to obtain information about the safety, tolerability and pharmacokinetics of BIIR 561 CL after continuous intravenous administration of two increasing doses in h...
Eligibility Criteria
Inclusion
- Healthy male and female volunteers
- Age \>= 60 years
- Broca index from -25% to +25%
- Written informed consent prior to admission to the study
Exclusion
- 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
Key Trial Info
Start Date :
August 1 2000
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT02223507
Start Date
August 1 2000
Last Update
August 22 2014
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