Status:
COMPLETED
Safety, Tolerability and Pharmacokinetics of the Fixed Dose Combination of BI 1744 CL Plus BI 54903 XX Via Respimat® B Versus the Free Combination of BI 1744 CL Via Respimat® A and BI 54903 XX Via Respimat® B in Healthy Male and Female Volunteers
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Healthy
Eligibility:
All Genders
21-50 years
Phase:
PHASE1
Brief Summary
The primary objective of this study was to compare the systemic exposure of BI 1744 BS and CD 1857 XX (the active metabolite of the pro-drug BI 54903 XX) at steady state following inhalation of the fi...
Eligibility Criteria
Inclusion
- Healthy males and females according to the following criteria: Based upon a complete medical history, including the physical examination, vital signs (Blood pressure (BP), Pulse rate (PR)), 12-lead Electrocardiogram (ECG), clinical laboratory tests
- Age \>= 21 and \<= 50 years
- BMI \>= 18.5 and \<= 29.9 kg/m2
- Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and the local legislation
Exclusion
- Any finding of the medical examination (including BP, PR and ECG) deviating from normal and of clinical relevance
- Any evidence of a clinically relevant concomitant disease
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- Surgery of the gastrointestinal tract (except appendectomy)
- Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
- History of relevant orthostatic hypotension, fainting spells or blackouts
- Chronic or relevant acute infections
- History of relevant allergy/hypersensitivity (including allergy to drug or its excipients)
- Intake of drugs with a long half-life (\> 24 hours) within at least one month or less than 10 half-lives of the respective drug prior to administration or during the trial
- Use of drugs which might reasonably influence the results of the trial based on the knowledge at the time of protocol preparation within 10 days prior to administration or during the trial
- Participation in another trial with an investigational drug within 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 trial days
- alcohol abuse (more than 40 g/day)
- Drug abuse
- Blood donation (\> 100 mL within four weeks prior to administration or during the trial)
- Excessive physical activities (within one week prior to administration or during the trial)
- Any laboratory value outside the reference range that is of clinical relevance
- Inability to comply with dietary regimen of trial site
- For female Subjects:
- Pregnancy
- Positive pregnancy test
- No adequate contraception (adequate contraception e.g. sterilization, intrauterine pessary (IUP), oral contraceptives)
- Inability to maintain this adequate contraception during the whole study period
- Lactation period
- Exclusion criteria specific for this study due to the known class side effect profile of ß2-mimetics and inhaled corticosteroids:
- Asthma or history of pulmonary hyperreactivity
- Hyperthyreosis
- Allergic rhinitis in need of treatment
- Clinically relevant cardiac arrhythmia
- Bacterial and viral infections of the lung including tuberculosis
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT02220660
Start Date
March 1 2009
Last Update
August 20 2014
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