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 - Full Text View

Purpose

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

Condition	Intervention	Phase
Healthy	Drug: Tiotropium Drug: BI 54903	Phase 1

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	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

Resource links provided by NLM:

Drug Information available for: Tiotropium bromide

U.S. FDA Resources

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Primary Outcome Measures:

AUC (Area Under Curve) for Tiotropium [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]
Cmax (Maximum measured concentration of the analyte in plasma) for Tiotropium [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]
AUC for CD 1857 [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]
Cmax for CD 1857 [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

AUC for BI 54903 [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]
Cmax for BI 54903 [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]
Ae0-24 (Amount of analyte that is eliminated in urine) for tiotropium [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]

Enrollment:	36
Study Start Date:	March 2011
Primary Completion Date:	June 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Treatment A: Tiotropium medium dose Oral inhalation daily for 21 days	Drug: Tiotropium Medium dose of oral inhalation
Experimental: Treatment A: BI 54903 high dose Oral inhalation daily for 21 days	Drug: BI 54903 Medium dose of oral inhalation
Experimental: Treatment B: Tiotropium medium dose Oral inhalation daily for 21 days	Drug: Tiotropium Medium dose of oral inhalation
Experimental: Treatment C: BI 54903 high dose Oral inhalation daily for 21 days	Drug: BI 54903 Medium dose of oral inhalation

Eligibility

Ages Eligible for Study:	21 Years to 50 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01309139

Locations

Germany
1298.2.1 Boehringer Ingelheim Investigational Site
Ingelheim, Germany

Sponsors and Collaborators

Boehringer Ingelheim Pharmaceuticals

Investigators

Study Chair:

Boehringer Ingelheim

Boehringer Ingelheim Pharmaceuticals

More Information

No publications provided

Responsible Party:	Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT01309139 History of Changes
Other Study ID Numbers:	1298.2, 2010-023780-18
Study First Received:	March 1, 2011
Last Updated:	November 16, 2011
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:

Tiotropium
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Cholinergic Antagonists

Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Bronchodilator Agents
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 21, 2013