- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01309139
Pharmacokinetics of the Fixed Dose Combination of Tiotropium Plus BI 54903 Versus the Combination of the Monoproducts of Tiotropium and BI 54903 in Healthy Volunteers
An Open Label, Randomised, Two-way Crossover Phase I Study to Assess Safety, Tolerability and Pharmacokinetics of the Fixed Dose Combination of Tiotropium Plus BI 54903 Via Respimat® B Versus the Combination of the Monoproducts of Tiotropium Via Respimat® A and BI 54903 Via Respimat® B in Healthy Volunteers
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
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 1
Kontakter og lokationer
Studiesteder
-
-
-
Ingelheim, Tyskland
- 1298.2.1 Boehringer Ingelheim Investigational Site
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion criteria:
- 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 to 50 years.
Exclusion criteria:
- 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
- History or evidence of relevant psychiatric disorders or neurological disorders
- History or evidence of relevant autonomic dysfunction (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 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
- Participation in another trial with an investigational drug within two months prior to administration or during the trial
- Smoker (more than 10 cigarettes daily)
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Crossover opgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Treatment A: Tiotropium medium dose
Oral inhalation daily for 21 days
|
Medium dose of oral inhalation
|
|
Eksperimentel: Treatment A: BI 54903 high dose
Oral inhalation daily for 21 days
|
Medium dose of oral inhalation
|
|
Eksperimentel: Treatment B: Tiotropium medium dose
Oral inhalation daily for 21 days
|
Medium dose of oral inhalation
|
|
Eksperimentel: Treatment C: BI 54903 high dose
Oral inhalation daily for 21 days
|
Medium dose of oral inhalation
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Area under the concentration time curve of CD 1857 in plasma over a uniform dosing interval τ (AUCτ,ss)
Tidsramme: on several time points until day 22
|
on several time points until day 22
|
|
Maximum concentration of CD 1857 in plasma at steady state (Cmax,ss)
Tidsramme: on several time points until day 22
|
on several time points until day 22
|
|
AUCτ,ss for Tiotropium
Tidsramme: on several time points until day 22
|
on several time points until day 22
|
|
Cmax,ss for Tiotropium
Tidsramme: on several time points until day 22
|
on several time points until day 22
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
AUCτ,ss for BI 54903
Tidsramme: on several time points until day 22
|
on several time points until day 22
|
|
Cmax,ss for BI 54903
Tidsramme: on several time points until day 22
|
on several time points until day 22
|
|
Ae0-24 (Amount of analyte that is eliminated in urine) for tiotropium
Tidsramme: on Day 1 and 21
|
on Day 1 and 21
|
|
Change in physical examination
Tidsramme: 9 weeks
|
9 weeks
|
|
Change in vital signs
Tidsramme: 9 weeks
|
9 weeks
|
|
Change in 12-lead electrocardiogram
Tidsramme: 9 weeks
|
9 weeks
|
|
Change in clinical laboratory tests
Tidsramme: 9 weeks
|
9 weeks
|
|
Occurrence of Adverse Events
Tidsramme: 9 weeks
|
9 weeks
|
|
Assessment of tolerability by the investigator
Tidsramme: 9 weeks
|
9 weeks
|
Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Lægemidlers fysiologiske virkninger
- Neurotransmittermidler
- Molekylære mekanismer for farmakologisk virkning
- Parasympatholytika
- Autonome agenter
- Agenter fra det perifere nervesystem
- Kolinerge antagonister
- Kolinerge midler
- Bronkodilatatorer
- Anti-astmatiske midler
- Respiratoriske midler
- Tiotropiumbromid
Andre undersøgelses-id-numre
- 1298.2
- 2010-023780-18 (EudraCT nummer: EudraCT)
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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