NCT Number: NCT02265666
Relative Bioavailability, Safety and Tolerability of Two Tablet Formulations of BIIL 284 BS
The objective of the present study is to investigate the relative bioavailability of BIIL 284 BS Tablet FF in comparison to the tablet C at a dose of 5 mg after a standard breakfast in healthy male volunteers
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Notify MeKey information
Conditions
Age range
21 year–50 year
Sex eligibility
Male
Study type
Interventional
Phase
Phase 1
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- All participants are healthy males
- Age range from 21 to 50 years
- Broca-Index: within +- 20% of 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 criteria
- Any finding of the medical examination (including blood pressure, pulse rate and ECG) 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 with 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 ten half-lives of the respective drug before enrollment in the study
- Use of any drugs which might influence the results of the trial (<= one week prior to administration or during the trial)
- Participation in another trial with an investigational drug (<= two months prior to administration or during the trial)
- Smoker (> 10 cigarettes or 3 cigars or 3 pipes/day)
- Inability to refrain from smoking on study days
- Alcohol abuse (> 60g/day)
- Drug abuse
- Blood donation (>= 100 mL within four weeks prior to administration or during the trial)
- Excessive physical activities (within the last week before the study )
- Any laboratory value outside the reference range of clinical relevance
Treatment and study plan
BIIL 284 BS tablet C
Drugstandard breakfast
OtherPrimary outcomes
-
AUC0-∞ (Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)
Time frame: up to 24 hours after drug administration
-
Cmax (Maximum measured concentration of the analyte in plasma)
Time frame: up to 24 hours after drug administration
Secondary outcomes
-
AUC0-tz (Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point)
Time frame: up to 24 hours after drug administration
-
tmax (Time from dosing to the maximum concentration of the analyte in plasma)
Time frame: up to 24 hours after drug administration
-
Terminal rate constant in plasma
Time frame: up to 24 hours after drug administration
-
t½ (Terminal half-life of the analyte in plasma)
Time frame: up to 24 hours after drug administration
-
MRTtot (total mean residence time)
Time frame: up to 24 hours after drug administration
-
CL/F (Apparent clearance of the analyte in plasma following extravascular administration)
Time frame: up to 24 hours after drug administration
-
Vz/F (Apparent volume of distribution of the analyte during the terminal phase)
Time frame: up to 24 hours after drug administration
-
Number of subjects with adverse events
Time frame: up to 8 days after last drug administration
-
Number of subjects with clinically significant findings in vital functions
Time frame: up to 8 days after last drug administration
blood pressure, pulse rate, ECG
-
Number of subjects with clinically significant findings in laboratory tests
Time frame: up to 8 days after last drug administration
Sponsors and collaborators
Lead sponsor
Boehringer Ingelheim
Industry
Registry information
Official study title
Randomised, Open-label, Two-way Crossover Study in Male Healthy Volunteers to Investigate the Relative Bioavailability of BIIL 284 BS 5 mg Tablet FF in Comparison to Tablet C After Ingestion of a Standardised Meal
Important dates
- Study start
- 2001
- Primary completion
- 2001
- First posted
- Oct 16, 2014
- Registry last updated
- Oct 16, 2014
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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