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Comparison of Salmeterol and Fluticasone Propionate Absorption From Salmeterol/Fluticasone Easyhaler With Seretide Diskus

Pharmacokinetic Study Comparing Two Salmeterol Fluticasone Propionate Device-metered Dry Powder Inhalers, Salmeterol/Fluticasone Easyhaler and Seretide Diskus 50/500 Mcg/Inhalation; a Randomised, Doubleblind,Single Centre, Single Dose, Crossover Study in Healthy Subjects

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01856621
Enrollment
48
Registered
2013-05-17
Start date
2013-05-31
Completion date
2013-09-30
Last updated
2014-01-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma

Brief summary

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.

Interventions

DRUGSeretide Diskus and charcoal

2 inhalations as a single dose

DRUGSeretide Diskus

2 inhalations as a single dose

DRUGSF Easyhaler and charcoal

2 inhalations as a single dose

DRUGSF Easyhaler

2 inhalations as a single dose

Sponsors

Orion Corporation, Orion Pharma
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Pharmacokinetic parameter Cmax of plasma salmeterol concentrationWithin 34 h
Pharmacokinetic parameter Cmax of plasma fluticasone propionate concentrationWithin 34 h
Pharmacokinetic parameter AUCt of plasma salmeterol concentrationWithin 34 h
Pharmacokinetic parameter AUCt of plasma fluticasone propionate concentrationWithin 34 h

Countries

Finland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026