Status:
COMPLETED
Relative Bioavailability, Pharmacokinetics, Safety and Tolerability of BIIL 284 BS in Healthy Volunteers
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Healthy
Eligibility:
MALE
21-50 years
Phase:
PHASE1
Brief Summary
The objective of the present study is to investigate the relative bioavailability of two BIIL 284 BS tablets (tablet C and tablet C) in comparison to the WIF tablet at a dose of 75 mg following a stan...
Eligibility Criteria
Inclusion
- All participants are healthy males
- Age range from 21 to 50 years
- Broca-Index: within +- 20% of their normal weight
- In accordance with Good Clinical Practice (GCP) and local legislation each volunteer is supposed to give their written informed consent prior to admission to the study
Exclusion
- Volunteers will be excluded from the study if the results of the medical examination or laboratory tests 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
- Volunteers with history of orthostatic hypotension, fainting spells or blackouts
- Volunteers with chronic or relevant acute infections
- Volunteers with history of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
- Volunteers who have taken a drug with a long half-life (\>= 24 hours) within one month or less than ten half-lives of the respective drug before enrollment in the study
- Volunteers who received any drugs which might influence the results of the trial the week previous 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 drink more than 60g of alcohol per day
- Volunteers who are dependent on drugs
- Volunteers who participated in excessive physical activities (e.g. competitive sports) within the last week before the study
- Volunteers who have donated blood within the last 4 weeks (\>= 100 mL)
Key Trial Info
Start Date :
November 1 1999
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT02265653
Start Date
November 1 1999
Last Update
October 16 2014
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