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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

NCT ID: NCT01309139

Last Updated: 2013-11-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-31

Brief Summary

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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

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment A: Tiotropium medium dose

Oral inhalation daily for 21 days

Group Type EXPERIMENTAL

Tiotropium

Intervention Type DRUG

Medium dose of oral inhalation

Treatment A: BI 54903 high dose

Oral inhalation daily for 21 days

Group Type EXPERIMENTAL

BI 54903

Intervention Type DRUG

Medium dose of oral inhalation

Treatment B: Tiotropium medium dose

Oral inhalation daily for 21 days

Group Type EXPERIMENTAL

Tiotropium

Intervention Type DRUG

Medium dose of oral inhalation

Treatment C: BI 54903 high dose

Oral inhalation daily for 21 days

Group Type EXPERIMENTAL

BI 54903

Intervention Type DRUG

Medium dose of oral inhalation

Interventions

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Tiotropium

Medium dose of oral inhalation

Intervention Type DRUG

Tiotropium

Medium dose of oral inhalation

Intervention Type DRUG

BI 54903

Medium dose of oral inhalation

Intervention Type DRUG

BI 54903

Medium dose of oral inhalation

Intervention Type DRUG

Eligibility Criteria

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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)

Minimum Eligible Age

21 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

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1298.2.1 Boehringer Ingelheim Investigational Site

Ingelheim, , Germany

Site Status

Countries

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Germany

Other Identifiers

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2010-023780-18

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1298.2

Identifier Type: -

Identifier Source: org_study_id