Status:
COMPLETED
Dose Extension Study of BIIX 1 XX in Healthy Young Male Volunteers
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Healthy
Eligibility:
MALE
21-50 years
Phase:
PHASE1
Brief Summary
Safety, tolerability and pharmacokinetic study of BIIX 1 XX in healthy male volunteers.
Eligibility Criteria
Inclusion
- Healthy males, based on a complete medical examination
- Age range from 21 to 50 years
- Participant must be within +/- 20 % of their normal weight (Broca-Index)
- Participant must provide written informed consent
Exclusion
- Any finding of the medical examination (including blood pressure, pulse rate and electrocardiogram) or laboratory tests deviating from normal and of clinical relevance
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- Diseases of the central nervous system (such as epilepsy) or psychiatric disorders
- 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 at least one month or less than then half-lives of the respective drug before enrolment in the study
- Use of any drugs which might influence the results of the trial within seven days prior to administration or during the trial
- Participation in another trial with an investigational drug within two months prior to start of the study
- Smoker (\> 10 cigarettes or 3 cigars or 3 pipes/day)
- Inability to refrain from smoking on study days
- Alcohol abuse
- Drug abuse
- Blood donation (\> 100 ml) within four weeks prior to administration
- Other disease or abnormality of clinical relevance
- Excessive physical activities within two weeks prior to administration or during the trial
Key Trial Info
Start Date :
January 1 1999
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT02198287
Start Date
January 1 1999
Last Update
July 23 2014
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.