Status:
TERMINATED
Increasing Dose Tolerance Study in Healthy Male Volunteers After Administration of BIII 890 CL
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Healthy
Eligibility:
MALE
21-50 years
Phase:
PHASE1
Brief Summary
The objective ot the present study is to obtain information about safety, tolerability and preliminary pharmacokinetics of BIII 890 CL after single intravenous administration of increasing doses in he...
Eligibility Criteria
Inclusion
- Healthy male subjects as determined by results of screening
- Age ≥ 21 and ≤ 50 years
- Broca index ≥ - 20% and ≤ + 20%
- Signed written informed consent in accordance with Good Clinical Practice and local legislation
Exclusion
- Results of the medical examination, laboratory tests or electrocardiogram recordings are judged by the clinical investigator to differ significantly from normal clinical values
- 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 trauma in the medical history or with psychiatric disorders or neurological disorders
- Known history of orthostatic hypotension, fainting spells or blackouts
- Chronic or relevant acute infections
- History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
- Intake of a drug with a long half-life (≥ 24 hours) within the last month or less than ten half-lives of the respective drug before enrolment in the study
- Intake of any other drugs which might influence the results of the trial during the week previous to the start of the study
- Participation in another study with an investigational drug within the last two months preceding this study
- Smokers (\> 10 cigarettes or 3 cigars or 3 pipes/day)
- Volunteers who are not able to refrain from smoking on study days
- Alcohol abuse (more than 60 g/day)
- Drug abuse
- Participation in excessive physical activities (e.g. competitive sports) within the last week before the study
- Blood donation (≥ 100 ml) within the last 4 weeks
Key Trial Info
Start Date :
April 1 1999
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
76 Patients enrolled
Trial Details
Trial ID
NCT02268136
Start Date
April 1 1999
Last Update
October 20 2014
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