Clinical Trials/NCT02254174

NCT02254174

Completed

Phase 1

A Randomised, Open-label Four-way Crossover Study to Evaluate Relative Bioavailability of Tiotropium and Salmeterol After Inhalation of a Fixed Combined Single Dose (7.5 μg Tiotropium, 25 μg Salmeterol, Inhalation Powder, Hard Capsule, HandiHaler®2), a Free Combined Single Dose of 18 μg Tiotropium [Spiriva® HandiHaler®] and 50 μg Salmeterol [Serevent® Diskus®], a Single Dose of 50μg Salmeterol (Serevent® Diskus®) and a Single Dose of 18 μg Tiotropium (Spiriva® HandiHaler®) in Healthy Male Volunteers

Boehringer Ingelheim0 sites36 target enrollmentMarch 2006

ConditionsHealthy

InterventionsTiotropium/Salmeterol Serevent® Diskus®Spiriva®

DrugsTiotropium/Salmeterol Serevent® Diskus®Spiriva®

Overview

Phase: Phase 1
Intervention: Tiotropium/Salmeterol
Conditions: Healthy
Sponsor: Boehringer Ingelheim
Enrollment: 36
Primary Endpoint: Cmax (maximum measured concentration of salmeterol in blood plasma)
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

Assessment of the relative bioavailability of a fixed dose combination of tiotropium and salmeterol compared to a free dose combination of the marketed products of tiotropium and salmeterol (Spiriva® and Serevent® Diskus®).

Assessment of the relative bioavailability of a fixed dose combination of tiotropium and salmeterol compared to tiotropium and salmeterol administered as individual mono substances from the marketed products.

Assessment of safety and tolerability of the fixed combination of tiotropium and salmeterol in a PE (Polyethylene) capsule administered via the HandiHaler® 2

Registry

clinicaltrials.gov

Start Date

March 2006

End Date

July 2006

Last Updated

11 years ago

Study Type

Interventional

Study Design

Crossover

Sex

Male

Investigators

Sponsor

Boehringer Ingelheim

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Healthy male based upon a complete medical history, including the physical examination, regarding vital signs (blood pressure (BP), pulse rate (PR)), 12-lead ECG (electrocardiogram) measurement, and clinical laboratory tests. There is no finding deviating from normal and of clinical relevance.
•There is no evidence of a clinically relevant concomitant disease
•Age ≥21 and ≤50 years
•BMI ≥18.5 and \<30 kg/m2 (Body Mass Index)
•Signed and dated written informed consent prior to admission to the study in accordance with GCP (Good Clinical Practice) and the local legislation

Exclusion Criteria

•Any finding of the medical examination (including BP, PR, and ECG measurements) deviating from normal and of clinical relevance
•Evidence of a clinically relevant concomitant disease
•Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
•Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
•History of relevant orthostatic hypotension, fainting spells or blackouts
•Chronic or relevant acute infections
•History of relevant allergy/hypersensitivity (including allergy to the drug or its excipients) as judged clinically relevant by the investigator
•Intake of drugs with a long half-life (\>24 hours) within at least 1 month or less than 10 half-lives of the respective drug prior to randomisation
•Use of drugs which might reasonably influence the results of the trial based on the knowledge at the time of protocol preparation within 10 days prior to enrolment in the study or during the study
•Participation in another trial with an investigational drug within 2 months prior to randomisation

Arms & Interventions

Tiotropium/Salmeterol

Intervention: Tiotropium/Salmeterol

Serevent® Diskus®

Intervention: Serevent® Diskus®

Spiriva®

Intervention: Spiriva®

Spiriva® and Serevent® Diskus®

Intervention: Serevent® Diskus®

Spiriva® and Serevent® Diskus®

Intervention: Spiriva®

Outcomes

Primary Outcomes

Cmax (maximum measured concentration of salmeterol in blood plasma)

Time Frame: Up to 8 hours after drug administration

Ae0-8 (urinary excretion of tiotropium over an 8 hour interval)

Time Frame: Up to 8 hours after drug administration

AUC0-∞ (area under the concentration-time curve of salmeterol in blood plasma over the time interval from 0 extrapolated to infinity);

Time Frame: Up to 8 hours after drug administration

Secondary Outcomes

tmax (time from dosing to the maximum concentration of in plasma)(Up to 8 hours after drug administration)
Number of participants with abnormal changes in clinical laboratory parameters(up to 90 days after first drug administration)
Number of participants with clinically significant changes in vital signs(up to 90 days after first drug administration)
MRTih (mean residence time in the body after inhalational administration)(Up to 8 hours after drug administration)
fet1-t2 (fraction of analyte eliminated in urine from time point t1 to time point t2)(up to 8 hours after inhalation)
Tolerability assessed by investigator on a 4-point scale(up to 90 days after first drug administration)
Number of participants with abnormal findings in physical examination(up to 90 days after first drug administration)
CLR,t1-t2 (renal clearance of the analyte from the time point t1 until the time point t2)(up to 8 hours after inhalation)
Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose)(Up to 8 hours after drug administration)
AUC0-tz (area under the concentration-time curve in plasma over the time interval from 0 to the time of the last quantifiable data point)(Up to 8 hours after drug administration)
AUC0-∞ (area under the concentration-time curve of tiotropium in blood plasma over the time interval from 0 extrapolated to infinity)(Up to 8 hours after drug administration)
Cmax (maximum measured concentration of tiotropium in blood plasma)(Up to 8 hours after drug administration)
AUCt1-t2 (area under the concentration time curve in plasma over the time interval t1 to t2)(up to 8 hours after inhalation)
λz (terminal rate constant in plasma)(Up to 8 hours after drug administration)
Aet1-t2 (amount of analyte that is eliminated in urine from the time point t1 to time point t2(up to 8 hours after inhalation)
t½ (terminal half-life of in plasma)(Up to 8 hours after drug administration)
CL/F (apparent clearance of in the plasma after extravascular administration)(Up to 8 hours after drug administration)
Number of participants with abnormal findings in 12-lead ECG(up to 90 days after first drug administration)
Number of participants with adverse events(up to 90 days after first drug administration)