Trial | NCT01766843  Report issue

Title

Comparison of Salmeterol and Fluticasone Propionate Absorption From Salmeterol/Fluticasone Easyhaler and Seretide Diskus
Bioequivalence Study Comparing Two Salmeterol/Fluticasone Propionate Dry Powder Inhalers, SF Easyhaler and Seretide Diskus 50/500 Mcg/Inhalation; Randomised, Double-blind, Single Centre, Single Dose, Crossover Study in Healthy Subjects

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    fluticasone salmeterol ...

  • Study Participants

    50
The purpose of this study is to compare the test product Salmeterol/fluticasone Easyhaler with the reference product Seretide Diskus in terms of drug absorbed in the bloodstream.
Study Started
Jan 31
2013
Primary Completion
May 31
2013
Study Completion
May 31
2013
Last Update
Jan 03
2014
Estimate

Drug Seretide Diskus and charcoal

2 inhalations as a single dose

Drug Seretide Diskus

2 inhalations as a single dose

Drug SF Easyhaler and charcoal

2 inhalations as a single dose

Drug SF Easyhaler

2 inhalations as a single dose

Seretide Diskus and charcoal Active Comparator

Single-dose of Seretide Diskus (50/500 mcg/inhalation) and charcoal

Seretide Diskus Active Comparator

Single-dose of Seretide Diskus (50/500 mcg/inhalation)

SF Easyhaler and charcoal Experimental

Salmeterol/fluticasone Easyhaler (50/500 mcg/inhalation) with charcoal

SF Easyhaler Experimental

Salmeterol/fluticasone Easyhaler (50/500 mcg/inhalation)

Criteria 

Inclusion Criteria:

Healthy males and females aged 18-60 years
Normal weight, at least 50 kg

Exclusion Criteria:

Evidence of clinically significant cardiovascular, renal, hepatic, haematological, GI, pulmonary, metabolic-endocrine, neurological or psychiatric disease.
Any clinically significant abnormal laboratory value or physical finding that may interfere with the interpretation of study results or constitute a health risk for the subject if he/she takes part in the study.
Any condition requiring regular concomitant treatment (including vitamins and herbal products) or likely to need any concomitant treatment during the study.
Known hypersensitivity to the active substance(s) or the excipient of the drug.
Pregnant or lactating females.
No Results Posted