Back to resultsPharmacokinetics of Salmeterol (Serevent®) After Inhalation With Metered Dose Inhaler (MDI) and Diskus® in Healthy Male Volunteers
Primary Purpose
Healthy
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Salmeterol Diskus low
Salmeterol Diskus high
Salmeterol MDI low
Salmeterol MDI high
Sponsored by
About this trial
This is an interventional treatment trial for Healthy
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
- 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)
- Any laboratory value outside the reference range that is of clinical relevance
Inability to comply with dietary regimen of study centre
Exclusion criterion specific for this study:
- Asthma or history of pulmonary hyperreactivity
- Allergy / hypersensitivity to Lactose monohydrate
- Hyperthyrosis
- Allergic rhinitis in need of treatment
- Cardiac arrhythmia
- Paroxysmal tachycardia (> 100 beats per minute)
- Aortic stenosis
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Active Comparator
Experimental
Experimental
Arm Label
Salmeterol MDI low
Salmeterol MDI high
Salmeterol Diskus low
Salmeterol Diskus high
Arm Description
Outcomes
Primary Outcome Measures
AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)
Cmax (maximum measured concentration of the analyte in plasma)
Secondary Outcome Measures
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)
AUCt1-t2 (Area under the concentration time curve of the analyte in plasma over the time interval t1 to t2)
tmax (time from dosing to the maximum concentration of the analyte in plasma)
λz (terminal rate constant in plasma)
t½ (terminal half-life of the analyte in plasma)
MRTinh (mean residence time of the analyte in the body after inhalational administration)
CL/F (apparent clearance of the analyte in the plasma after extravascular administration)
Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose)
Aet1-t2 (amount of analyte that was eliminated in urine from the time interval t1 to t2)
fet1-t2 (fraction of administered drug excreted unchanged in urine from time point t1 to t2)
CLR,t1-t2 (renal clearance of the analyte in plasma from the time point t1 to t2)
Number of participants with abnormal findings in physical examination
Number of participants with clinically significant changes in vital signs
Number of participants with abnormal findings in ECG
Number of participants with abnormal changes in clinical laboratory parameters
Number of participants with adverse events
Full Information
NCT ID
NCT02254226
First Posted
September 29, 2014
Last Updated
September 29, 2014
Sponsor
Boehringer Ingelheim
1. Study Identification
Unique Protocol Identification Number
NCT02254226
Brief Title
Pharmacokinetics of Salmeterol (Serevent®) After Inhalation With Metered Dose Inhaler (MDI) and Diskus® in Healthy Male Volunteers
Official Title
A Randomised, Open-label Four-way Crossover Study to Evaluate Pharmacokinetics of Salmeterol (Serevent®) After Inhalation of a 25 μg and 50 μg Single Dose (Metered Dose Inhaler) and a 50 μg and 100 μg Single Dose (Diskus®) in Healthy Male Volunteers
Study Type
Interventional
2. Study Status
Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
November 2004 (undefined)
Primary Completion Date
January 2005 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boehringer Ingelheim
4. Oversight
5. Study Description
Brief Summary
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
To test a system of ordered null hypotheses regarding the exposure of two dose levels of Serevent ® Diskus ® and Serevent ® MDI
To get data about the systemic drug exposure of 25 μg Serevent ® MDI and of 50 μg Serevent ® Diskus ®
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
26 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Salmeterol MDI low
Arm Type
Experimental
Arm Title
Salmeterol MDI high
Arm Type
Active Comparator
Arm Title
Salmeterol Diskus low
Arm Type
Experimental
Arm Title
Salmeterol Diskus high
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Salmeterol Diskus low
Intervention Type
Drug
Intervention Name(s)
Salmeterol Diskus high
Intervention Type
Drug
Intervention Name(s)
Salmeterol MDI low
Intervention Type
Drug
Intervention Name(s)
Salmeterol MDI high
Primary Outcome Measure Information:
Title
AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)
Time Frame
Up to 6 hours after drug administration
Title
Cmax (maximum measured concentration of the analyte in plasma)
Time Frame
Up to 6 hours after drug administration
Secondary Outcome Measure Information:
Title
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)
Time Frame
Up to 6 hours after drug administration
Title
AUCt1-t2 (Area under the concentration time curve of the analyte in plasma over the time interval t1 to t2)
Time Frame
Up to 6 hours after inhalation
Title
tmax (time from dosing to the maximum concentration of the analyte in plasma)
Time Frame
Up to 6 hours after drug administration
Title
λz (terminal rate constant in plasma)
Time Frame
Up to 6 hours after drug administration
Title
t½ (terminal half-life of the analyte in plasma)
Time Frame
Up to 6 hours after drug administration
Title
MRTinh (mean residence time of the analyte in the body after inhalational administration)
Time Frame
Up to 6 hours after drug administration
Title
CL/F (apparent clearance of the analyte in the plasma after extravascular administration)
Time Frame
Up to 6 hours after drug administration
Title
Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose)
Time Frame
Up to 6 hours after drug administration
Title
Aet1-t2 (amount of analyte that was eliminated in urine from the time interval t1 to t2)
Time Frame
Up to 6 hours after inhalation
Title
fet1-t2 (fraction of administered drug excreted unchanged in urine from time point t1 to t2)
Time Frame
Up to 6 hours after inhalation
Title
CLR,t1-t2 (renal clearance of the analyte in plasma from the time point t1 to t2)
Time Frame
Up to 6 hours after inhalation
Title
Number of participants with abnormal findings in physical examination
Time Frame
Up to 15 days after last drug administration
Title
Number of participants with clinically significant changes in vital signs
Time Frame
Up to 15 days after last drug administration
Title
Number of participants with abnormal findings in ECG
Time Frame
Up to 15 days after last drug administration
Title
Number of participants with abnormal changes in clinical laboratory parameters
Time Frame
Up to 15 days after last drug administration
Title
Number of participants with adverse events
Time Frame
Up to 15 days after last drug administration
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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)
Any laboratory value outside the reference range that is of clinical relevance
Inability to comply with dietary regimen of study centre
Exclusion criterion specific for this study:
Asthma or history of pulmonary hyperreactivity
Allergy / hypersensitivity to Lactose monohydrate
Hyperthyrosis
Allergic rhinitis in need of treatment
Cardiac arrhythmia
Paroxysmal tachycardia (> 100 beats per minute)
Aortic stenosis
12. IPD Sharing Statement
Links:
URL
http://trials.boehringer-ingelheim.com
Description
Related Info
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Pharmacokinetics of Salmeterol (Serevent®) After Inhalation With Metered Dose Inhaler (MDI) and Diskus® in Healthy Male Volunteers
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