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

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Salmeterol MDI low; Drug: Salmeterol MDI high; Drug: Salmeterol Diskus high; Drug: Salmeterol Diskus low

Study type: Interventional

Funder types: Industry

Identifiers

NCT02254226

1184.8

Details and patient eligibility

About

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 ®

Enrollment: 26 patients

Sex: Male

Ages: 21 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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26 participants in 4 patient groups

Salmeterol MDI low

Experimental group

Treatment:

Drug: Salmeterol MDI low

Salmeterol MDI high

Active Comparator group

Treatment:

Drug: Salmeterol MDI high

Salmeterol Diskus low

Experimental group

Treatment:

Drug: Salmeterol Diskus low

Salmeterol Diskus high

Experimental group

Treatment:

Drug: Salmeterol Diskus high