Pharmacokinetics of Salmeterol (Serevent®) After Inhalation With Metered Dose Inhaler (MDI) and Diskus® in Healthy Male Volunteers

NCT ID: NCT02254226

Last Updated: 2014-10-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-11-30

Brief Summary

1. To compare the systemic drug exposure of 100 μg Serevent ® Diskus ® with that of 50 μg Serevent ® MDI with sufficient precision so that in combination with a second trial it can be demonstrated that the systemic drug exposure of a new formulation of salmeterol xinafoate is not superior to that of Serevent ® MDI

2. To test a system of ordered null hypotheses regarding the exposure of two dose levels of Serevent ® Diskus ® and Serevent ® MDI

3. To get data about the systemic drug exposure of 25 μg Serevent ® MDI and of 50 μg Serevent ® Diskus ®

Conditions

Healthy

Study Design

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

Study Groups

Salmeterol MDI low

Group Type: EXPERIMENTAL

Salmeterol MDI low

Intervention Type: DRUG

Salmeterol MDI high

Group Type: ACTIVE_COMPARATOR

Salmeterol MDI high

Intervention Type: DRUG

Salmeterol Diskus low

Group Type: EXPERIMENTAL

Salmeterol Diskus low

Intervention Type: DRUG

Salmeterol Diskus high

Group Type: EXPERIMENTAL

Salmeterol Diskus high

Intervention Type: DRUG

Interventions

Salmeterol Diskus low

Intervention Type: DRUG

Salmeterol Diskus high

Intervention Type: DRUG

Salmeterol MDI low

Intervention Type: DRUG

Salmeterol MDI high

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Healthy males 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 ECG (electrocardiogram) , clinical laboratory tests 1.1 No finding deviating from normal and of clinical relevance 1.2 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 Good Clinical Practice (GCP) and the local legislation.

Exclusion Criteria

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

2. Surgery of gastrointestinal tract (except appendectomy)

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

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

5. Chronic or relevant acute infections

6. History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator

7. 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 administration or during the trial.

8. 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 administration or during the trial.

9. Participation in another trial with an investigational drug within 2 months prior to administration or during the trial.

10. Smoker (more than 10 cigarettes or three cigars or three pipes per day)

11. Inability to refrain from smoking on trial days

12. Alcohol abuse (more than 60 g/day)

13. Drug abuse

14. Blood donation (more than 100 mL within 4 weeks prior to administration or during the trial)

15. Excessive physical activities (within 1 week prior to administration or during the trial)

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

17. Inability to comply with dietary regimen of study centre

Exclusion criterion specific for this study:

18. Asthma or history of pulmonary hyperreactivity

19. Allergy / hypersensitivity to Lactose monohydrate

20. Hyperthyrosis

21. Allergic rhinitis in need of treatment

22. Cardiac arrhythmia

23. Paroxysmal tachycardia (> 100 beats per minute)

24. Aortic stenosis

• 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

1184.8

Identifier Type: -

Identifier Source: org_study_id