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Completed

NCT Number: NCT01766843

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

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.

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Orion Pharma Clinical Pharmacology Unit

Espoo, Finland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Seretide Diskus and charcoal

Drug

2 inhalations as a single dose

SERETIDE Diskus

Drug

2 inhalations as a single dose

SF Easyhaler and charcoal

Drug

2 inhalations as a single dose

SF Easyhaler

Drug

2 inhalations as a single dose

Primary outcomes

  1. Pharmacokinetic parameter Cmax of plasma salmeterol concentration

    Time frame: Within 34 h

  2. Pharmacokinetic parameter Cmax of plasma fluticasone propionate concentration

    Time frame: Within 34 h

  3. Pharmacokinetic parameter AUCt of plasma salmeterol concentration

    Time frame: within 34 h

  4. Pharmacokinetic parameter AUCt of plasma fluticasone propionate concentration

    Time frame: within 34 h

Sponsors and collaborators

Lead sponsor

Orion Corporation, Orion Pharma

Industry

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Jan 11, 2013
Registry last updated
Jan 3, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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