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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Tiotropium; Drug: BI 54903

• Registration Number: NCT01309139
• Lead Sponsor: Boehringer Ingelheim

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

Detailed Description

Not available

Study Timeline

• Study Start: 2011-03
• Study First Submitted: 2011-03-01
• Study First Submitted QC: 2011-03-03
• Study First Posted: 2011-03-04
• Primary Completion: 2011-06
• Status Verified: 2013-10
• Last Update Submitted: 2013-10-31
• Last Update Posted: 2013-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Treatment B: Tiotropium medium dose	Tiotropium	Oral inhalation daily for 21 days
Treatment A: BI 54903 high dose	BI 54903	Oral inhalation daily for 21 days
Treatment C: BI 54903 high dose	BI 54903	Oral inhalation daily for 21 days
Treatment A: Tiotropium medium dose	Tiotropium	Oral inhalation daily for 21 days

Primary Outcome Measures

Name	Time	Method
Maximum concentration of CD 1857 in plasma at steady state (Cmax,ss)	on several time points until day 22
Cmax,ss for Tiotropium	on several time points until day 22
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
AUCτ,ss for Tiotropium	on several time points until day 22

Secondary Outcome Measures

Name	Time	Method
AUCτ,ss for BI 54903	on several time points until day 22
Change in physical examination	9 weeks
Change in vital signs	9 weeks
Change in 12-lead electrocardiogram	9 weeks
Change in clinical laboratory tests	9 weeks
Occurrence of Adverse Events	9 weeks
Assessment of tolerability by the investigator	9 weeks
Cmax,ss for BI 54903	on several time points until day 22
Ae0-24 (Amount of analyte that is eliminated in urine) for tiotropium	on Day 1 and 21

Trial Locations

Locations (1)

1298.2.1 Boehringer Ingelheim Investigational Site; 🇩🇪 Ingelheim, Germany