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

NCT02254226 | Completed Phase 1

• 1 other identifier: 1184.8
• Study Type: interventional
• Target: 26
• Locations: 0 countries
• Sites: N/A

Brief Summary

1. 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. 2.To test a system of ordered null hypotheses regarding the exposure of two dose levels of Serevent ® Diskus ® and Serevent ® MDI
3. 3.To get data about the systemic drug exposure of 25 μg Serevent ® MDI and of 50 μg Serevent ® Diskus ®

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

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

  Up to 6 hours after drug administration

• Cmax (maximum measured concentration of the analyte in plasma)

  Up to 6 hours after drug administration

Secondary Outcomes (16)

• AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point)

  Up to 6 hours after drug administration

• AUCt1-t2 (Area under the concentration time curve of the analyte in plasma over the time interval t1 to t2)

  Up to 6 hours after inhalation

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

  Up to 6 hours after drug administration

• λz (terminal rate constant in plasma)

  Up to 6 hours after drug administration

• t½ (terminal half-life of the analyte in plasma)

  Up to 6 hours after drug administration

Study Arms (4)

Salmeterol MDI low

EXPERIMENTAL

Drug: Salmeterol MDI low

Salmeterol MDI high

ACTIVE COMPARATOR

Drug: Salmeterol MDI high

Salmeterol Diskus low

EXPERIMENTAL

Drug: Salmeterol Diskus low

Salmeterol Diskus high

EXPERIMENTAL

Drug: Salmeterol Diskus high

Interventions

Salmeterol Diskus low DRUG

Salmeterol Diskus low

Salmeterol Diskus high DRUG

Salmeterol Diskus high

Salmeterol MDI low DRUG

Salmeterol MDI low

Salmeterol MDI high DRUG

Salmeterol MDI high

Eligibility Criteria

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

You may qualify if:

• 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
• 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 Good Clinical Practice (GCP) and the local legislation.

You may not qualify if:

• Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
• Surgery of gastrointestinal tract (except appendectomy)
• 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 allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged 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 administration or during the trial.
• 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.
• Participation in another trial with an investigational drug within 2 months prior to administration or during the trial.
• Smoker (more than 10 cigarettes or three cigars or three pipes per day)
• Inability to refrain from smoking on trial days
• Alcohol abuse (more than 60 g/day)
• Drug abuse
• Blood donation (more than 100 mL within 4 weeks prior to administration or during the trial)
• Excessive physical activities (within 1 week prior to administration or during the trial)

Sponsors & Collaborators

• Boehringer Ingelheim: lead

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: November 1, 2004
• Primary Completion: January 1, 2005
• Last Updated: October 1, 2014

Record last verified: 2014-09