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

NCT ID: NCT02254174

Last Updated: 2014-10-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-03-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Tiotropium/Salmeterol

Group Type: EXPERIMENTAL

Tiotropium/Salmeterol

Intervention Type: DRUG

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

Serevent® Diskus®

Group Type: ACTIVE_COMPARATOR

Serevent® Diskus®

Intervention Type: DRUG

Spiriva®

Group Type: ACTIVE_COMPARATOR

Spiriva®

Intervention Type: DRUG

Spiriva® and Serevent® Diskus®

Group Type: ACTIVE_COMPARATOR

Serevent® Diskus®

Intervention Type: DRUG

Spiriva®

Intervention Type: DRUG

Interventions

Tiotropium/Salmeterol

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

Intervention Type: DRUG

Serevent® Diskus®

Intervention Type: DRUG

Spiriva®

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. 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

2. Age ≥21 and ≤50 years

3. BMI ≥18.5 and <30 kg/m2 (Body Mass Index)

4. 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

1. Any finding of the medical examination (including BP, PR, and ECG measurements) deviating from normal and of clinical relevance

2. Evidence of a clinically relevant concomitant disease

3. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders

4. Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders

5. History of relevant orthostatic hypotension, fainting spells or blackouts

6. Chronic or relevant acute infections

7. History of relevant allergy/hypersensitivity (including allergy to the drug or its excipients) as judged clinically relevant by the investigator

8. 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

9. 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

10. Participation in another trial with an investigational drug within 2 months prior to randomisation

11. Smoker (>10 cigarettes or >3 cigars or >3 pipes/day)

12. Inability to refrain from smoking on trial days as judged by the investigator

13. Alcohol abuse (more than 40 g alcohol a day)

14. Drug abuse

15. Blood donation (more than 100 mL blood within 4 weeks prior to randomisation or during the trial)

16. Excessive physical activities within 1 week prior to randomisation or during the trial

17. Any laboratory value outside the reference range that is of clinical relevance

18. Inability to comply with dietary regimen of the study centre

19. Asthma or history of pulmonary hyperreactivity

20. Hyperthyrosis

21. Allergic rhinitis in need of treatment

22. Clinically relevant cardiac arrhythmia

23. Paroxysmal tachycardia (>100 beats per minute)

24. Hypersensitivity to tiotropium and/or related drugs of this class

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

1184.11

Identifier Type: -

Identifier Source: org_study_id