Status:
COMPLETED
Single Rising Dose Tolerability Study of BIBN 4096 BS in Healthy Male and Female Volunteers
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Healthy
Eligibility:
All Genders
21-50 years
Phase:
PHASE1
Brief Summary
The objective of the present study is to obtain information about the safety, tolerability and pharmacokinetics of BIBN 4096 BS after single intranasal administration of increasing doses in healthy ma...
Eligibility Criteria
Inclusion
- Participants should be healthy males and females
- Age range from 21 to 50 years
- Within +- 20% of their normal weight (Broca-Index)
- All female volunteers must use a safe contraception (i.e. oral contraceptive, spiral; sterilized) and must have a negative pregnancy test
- In accordance with Good Clinical Practice (GCP) and local legislation each volunteer is supposed to give his written informed consent prior to admission to the study
- Each subject will have his medical history taken and will receive a complete medical examination (incl. blood pressure and pulse rate measurements) as well as a 12-lead Electrocardiogram (ECG) within 14 days before the first administration of the test substance
- Haematopoietic, hepatic and renal function test will be carried out in the laboratory
- The subjects will fast for 12 hours before collection of specimens for all laboratory evaluations
Exclusion
- Volunteers will be excluded from the study if the results of the medical examination or laboratory tests (especially those which indicate liver malfunction) are judged by the clinical 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) or with psychiatric disorders
- History of orthostatic hypotension, fainting spells or blackouts
- Chronic or relevant acute infections (especially common cold with rhinitis)
- 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 ten half-lives of the respective drug before enrolment in the study
- Use 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
- Smoker (\> 10 cigarettes or 3 cigars or 3 pipes/day)
- Inability to refrain from smoking on study days
- Alcohol abuse (\> 40g/day)
- Drug abuse
- Blood donation ( \>= 100 ml) within the last 4 weeks
- Excessive physical activities (e.g. competitive sports) within the last week before the study
- Pregnant and/or lactating volunteers
Key Trial Info
Start Date :
July 1 1999
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT02198326
Start Date
July 1 1999
Last Update
July 23 2014
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