Skip to main content
OpenTrials
Completed

NCT Number: NCT02162485

Pharmacokinetic Study Comparing Salmeterol/Fluticasone Easyhaler Products and Seretide Diskus

The purposes of this study is to compare the test products Salmeterol/fluticasone Easyhaler with marketed product Seretide Diskus in terms of the drug absorbed into the blood stream

Completed

Looking for future studies?

Notify Me

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 Pharmacology Unit

Espoo, Finland

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Written informed consent obtained
  • Good general health ascertained by detailed medical history, and laboratory and physical examinations

Exclusion criteria

  • Evidence of a clinically significant cardiovascular, renal, hepatic, haematological, GI, pulmonary, metabolic-endocrine, neurological or psychiatric disease within the previous 2 years
  • Any condition requiring regular concomitant treatment (including vitamins and herbal products) or likely to need any concomitant treatment during the study. As an exception, paracetamol and ibuprofen for occasional pain are allowed
  • Known hypersensitivity to the active substance(s) or the excipient (lactose, which contains small amounts of milk protein) of the drug
  • Pregnant or lactating females

Treatment and study plan

Salmeterol/fluticasone Easyhaler

Drug

Salmeterol/fluticasone Easyhaler with charcoal

Drug

SERETIDE Diskus

Drug

Seretide Diskus with charcoal

Drug

Primary outcomes

  1. Cmax of plasma salmeterol and fluticasone propionate

    Time frame: within 34 h

  2. AUCt of plasma salmeterol and fluticasone propionate

    Time frame: 34 h

Sponsors and collaborators

Lead sponsor

Orion Corporation, Orion Pharma

Industry

Registry information

Official study title

Pharmacokinetic Study Comparing Salmeterol/Fluticasone Easyhaler Products and Seretide Diskus 50/500 µG/Inhalation; A Randomised, Open, Single Centre, Single Dose, Crossover Study in Healthy Subjects

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jun 12, 2014
Registry last updated
Sep 29, 2015

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.