Healthy
Conditions
Brief summary
The primary objective is to compare the systemic exposure to tiotropium and CD 1857 after treatment with the fixed dose combination (fixed dose combination (FDC), Treatment A) of tiotropium plus BI 54903 (ethanolic solution for inhalation (EIS), Respimat (RMT) B) with the systemic exposure following inhalation of the free combination (Treatment B) of tiotropium (aqueous solution for inhalation (AIS), RMT A) plus BI 54903 (EIS, RMT B), when administered once-daily over 21 days via Respimat(R) (RMT). The secondary objectives are: to compare the systemic exposure to tiotropium and CD 1857 after single dose administration of FDC and of the free combination of tiotropium/BI 54903 to compare the systemic exposure to BI 54903 after a single dose and at steady state after multiple doses of the FDC and of the free combination of tiotropium/BI 54903 to compare the safety and tolerability of tiotropium and BI 54903 when administered as FDC and as free dose combination, respectively
Interventions
DRUGTiotropium
Medium dose of oral inhalation
DRUGBI 54903
Medium dose of oral inhalation
Sponsors
Boehringer Ingelheim
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
1. 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. 2. Age 21 to 50 years.
Exclusion criteria
1. Any finding of the medical examination (including BP, PR and ECG) deviating from normal and of clinical relevance 2. Any evidence of a clinically relevant concomitant disease 3. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders 4. History or evidence of relevant psychiatric disorders or neurological disorders 5. History or evidence of relevant autonomic dysfunction (orthostatic hypotension, fainting spells or blackouts) 6. Chronic or relevant acute infections 7. History of relevant allergy/hypersensitivity (including allergy to drug or its excipients) 8. Intake of any prescription drugs or over-the-counter (over the counter (OTC)) medication (vitamins, herbal supplements, dietary supplements) 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 9. Participation in another trial with an investigational drug within two months prior to administration or during the trial 10. Smoker (more than 10 cigarettes daily)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area under the concentration time curve of CD 1857 in plasma over a uniform dosing interval τ (AUCτ,ss) | on several time points until day 22 |
| Maximum concentration of CD 1857 in plasma at steady state (Cmax,ss) | on several time points until day 22 |
| AUCτ,ss for Tiotropium | on several time points until day 22 |
| Cmax,ss for Tiotropium | on several time points until day 22 |
Secondary
| Measure | Time frame |
|---|---|
| AUCτ,ss for BI 54903 | on several time points until day 22 |
| Cmax,ss for BI 54903 | on several time points until day 22 |
| Change in 12-lead electrocardiogram | 9 weeks |
| Change in physical examination | 9 weeks |
| Change in vital signs | 9 weeks |
| Ae0-24 (Amount of analyte that is eliminated in urine) for tiotropium | on Day 1 and 21 |
| Change in clinical laboratory tests | 9 weeks |
| Occurrence of Adverse Events | 9 weeks |
| Assessment of tolerability by the investigator | 9 weeks |
Countries
Germany
Outcome results
None listed