Pharmacokinetics of Salmeterol Via HandiHaler® in Healthy Male Volunteers

NCT02254187 | Completed Phase 1

• 1 other identifier: 1184.17
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

The objective of this study is to investigate if the systemic drug exposure of at least 25 μg and perhaps 50 μg salmeterol presented as inhalation powder in PE capsules and administered via HandiHaler® 2 does not exceed that of 50 μg Serevent® Diskus® and to investigate safety and tolerability of salmeterol presented as inhalation powder in PE capsules and administered via HandiHaler® 2

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

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

  up to 8 hours after drug administration

• Cmax (maximum measured concentration of salmeterol in blood plasma)

  up to 8 hours after drug administration

Secondary Outcomes (13)

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

  up to 8 hours after drug administration

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

  up to 8 hours after drug administration

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

  up to 8 hours after drug administration

• λz (terminal rate constant in plasma)

  up to 8 hours after drug administration

• t½ (terminal half-life of salmeterol in plasma)

  up to 8 hours after drug administration

Study Arms (3)

Salmeterol capsule via Handihaler - low

EXPERIMENTAL

Drug: Salmeterol capsule - low

Salmeterol capsule via Handihaler - high

EXPERIMENTAL

Drug: Salmeterol capsule - high

Salmeterol via Serevent® Diskus®

ACTIVE COMPARATOR

Drug: Salmeterol via Serevent® Diskus®

Interventions

Salmeterol capsule - low DRUG

Salmeterol capsule via Handihaler - low

Salmeterol capsule - high DRUG

Salmeterol capsule via Handihaler - high

Salmeterol via Serevent® Diskus® DRUG

Salmeterol via Serevent® Diskus®

Eligibility Criteria

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

You may qualify if:

• Healthy male based upon a complete medical history, including the physical examination, regarding vital signs ((Blood Pressure (BP), Pulse Rate (PR)), 12-lead ECG 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.
• 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:

• Any finding of the medical examination (including BP, PR, and ECG measurements) deviating from normal and of clinical relevance
• Evidence of a clinically relevant concomitant disease
• Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
• 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 relevant allergy/hypersensitivity (including allergy to the drug or its excipients) as judged clinically relevant 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 randomization
• 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 randomization
• Participation in another trial with an investigational drug within 2 months prior to randomization
• Smoker (\>10 cigarettes or \>3 cigars or \>3 pipes/day)
• Inability to refrain from smoking on trial days as judged by the investigator
• Alcohol abuse (more than 60 g alcohol a day)
• Drug abuse
• Blood donation (more than 100 mL blood within 4 weeks prior to randomization or during the trial)

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Interventions

Salmeterol Xinafoate

Intervention Hierarchy (Ancestors)

Albuterol; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Phenethylamines; Ethylamines

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: September 1, 2005
• Primary Completion: October 1, 2005
• Last Updated: October 1, 2014

Record last verified: 2014-09