- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02265666
Relative Bioavailability, Safety and Tolerability of Two Tablet Formulations of BIIL 284 BS
October 15, 2014 updated by: Boehringer Ingelheim
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
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
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
16
Phase
- Phase 1
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years to 50 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: BIIL 284 BS Tablet FF
|
|
Active Comparator: BIIL 284 BS tablet C
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
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
|
up to 24 hours after drug administration
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of subjects with adverse events
Time Frame: up to 8 days after last drug administration
|
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
|
up to 8 days after last drug administration
|
Number of subjects with clinically significant findings in laboratory tests
Time Frame: up to 8 days after last drug administration
|
up to 8 days after last drug administration
|
|
t½ (Terminal half-life of the analyte in plasma)
Time Frame: up to 24 hours after drug administration
|
up to 24 hours after drug administration
|
|
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
|
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
|
up to 24 hours after drug administration
|
|
Terminal rate constant in plasma
Time Frame: up to 24 hours after drug administration
|
up to 24 hours after drug administration
|
|
MRTtot (total mean residence time)
Time Frame: up to 24 hours after drug administration
|
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
|
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
|
up to 24 hours after drug administration
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2001
Primary Completion (Actual)
November 1, 2001
Study Registration Dates
First Submitted
October 15, 2014
First Submitted That Met QC Criteria
October 15, 2014
First Posted (Estimate)
October 16, 2014
Study Record Updates
Last Update Posted (Estimate)
October 16, 2014
Last Update Submitted That Met QC Criteria
October 15, 2014
Last Verified
October 1, 2014
More Information
Terms related to this study
Other Study ID Numbers
- 543.31
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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