Relative Bioavailability of Tiotropium and Salmeterol After Inhalation of a Fixed Combined Dose Compared to Monocomponents in Healthy Male Volunteers

NCT02254174 | Completed Phase 1

• 1 other identifier: 1184.11
• Study Type: interventional
• Target: 36
• Locations: 0 countries
• Sites: N/A

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

Conditions

Healthy

Outcome Measures

Primary Outcomes (3)

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

  Up to 8 hours after drug administration

• Cmax (maximum measured concentration of salmeterol in blood plasma)

  Up to 8 hours after drug administration

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

  Up to 8 hours after drug administration

Secondary Outcomes (19)

• 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

• tmax (time from dosing to the maximum concentration of in plasma)

  Up to 8 hours after drug administration

Study Arms (4)

Tiotropium/Salmeterol

EXPERIMENTAL

Drug: Tiotropium/Salmeterol

Serevent® Diskus®

ACTIVE COMPARATOR

Drug: Serevent® Diskus®

Spiriva®

ACTIVE COMPARATOR

Drug: Spiriva®

Spiriva® and Serevent® Diskus®

ACTIVE COMPARATOR

Drug: Serevent® Diskus®; Drug: Spiriva®

Interventions

Tiotropium/Salmeterol DRUG

Fixed dose combination of tiotropium 7.5 μg and salmeterol 25 μg inhalation powder, PE capsule via HandiHaler®

Tiotropium/Salmeterol

Serevent® Diskus® DRUG

Serevent® Diskus®; Spiriva® and Serevent® Diskus®

Spiriva® DRUG

Spiriva®; Spiriva® and Serevent® Diskus®

Eligibility Criteria

• Age: 21 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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
• Smoker (\>10 cigarettes or \>3 cigars or \>3 pipes/day)
• Inability to refrain from smoking on trial days as judged by the investigator
• Alcohol abuse (more than 40 g alcohol a day)
• Drug abuse
• Blood donation (more than 100 mL blood within 4 weeks prior to randomisation or during the trial)

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Interventions

Tiotropium Bromide; Salmeterol Xinafoate

Intervention Hierarchy (Ancestors)

Scopolamine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring; Albuterol; Ethanolamines; Amino Alcohols; Alcohols; Amines; Phenethylamines; Ethylamines

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2014
• First Posted: October 1, 2014
• Study Start: March 1, 2006
• Primary Completion: July 1, 2006
• Last Updated: October 1, 2014

Record last verified: 2014-09