Status:
COMPLETED
Single Increasing Doses of BIII 890 CL in Healthy Young Male Volunteers and in Healthy Elderly Male and Female Volunteers
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Healthy
Eligibility:
All Genders
21+ years
Phase:
PHASE1
Brief Summary
Safety, tolerability and pharmacokinetics of BIII 890
Eligibility Criteria
Inclusion
- Participants in the study should be healthy males, range from 21 to 50 years of age and be within +- 20% of their normal weight (Broca-Index) and healthy elderly males and females, \> 60 years of age and be within +-25 % of their normal weight (Broca-Index)
- In accordance with good clinical practice (GCP) and the local legislation all volunteers will have given their written informed consent prior to admission to the study
Exclusion
- Volunteers were excluded from the study if the results of the medical examination, laboratory tests or ECG recordings are judged by the investigator to differ significantly from normal clinical values
- Volunteers with known gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- Volunteers with diseases of the central nervous system (such as epilepsy), central nervous system (CNS) trauma in their medical history or with psychiatric disorders or neurological disorders
- Volunteers with known history of relevant orthostatic hypotension, fainting spells or blackouts
- Volunteers with chronic or relevant acute infections
- Volunteers with history of allergy/hypersensitivity (including drug allergy) which was deemed relevant to the trial as, judged by the investigator
- Volunteers who had taken a drug 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
- Volunteers who received any other drugs which could influence the results of the trial during the week prior to the start of the study
- Volunteers who participated in another study with an investigational drug within the last two months preceding this study
- Volunteers who smoke (\> 10 cigarettes or 3 cigars or 3 pipes/day)
- Volunteers who were not able to refrain from smoking on study days
- Volunteers who drunk more than 60 g of alcohol per day
- Volunteers who were dependent on drugs
- Volunteers who participated in excessive physical activities (e.g. competitive sports) during the last week before the study
- Volunteers who donated blood within the last 4 weeks (≥ 100 mL)
Key Trial Info
Start Date :
January 1 2000
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
73 Patients enrolled
Trial Details
Trial ID
NCT02269215
Start Date
January 1 2000
Last Update
October 21 2014
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