Pharmacokinetic Study Comparing Salmeterol/Fluticasone Easyhaler and Seretide Diskus

Asthma Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03060044
• Other study ID #: 3106010
• Status: Completed
• Phase: Phase 1
• First received: February 17, 2017
• Last updated: March 2, 2017
• Start date: July 2016
• Est. completion date: November 2016

Study information

• Verified date: August 2016
• Source: Orion Corporation, Orion Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: November 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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, hematological, GI, pulmonary, metabolic-endocrine, neurological or psychiatric disease within the previous 2 years

• any condition requiring 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

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• Salmeterol/fluticasone Easyhaler

• Salmeterol/fluticasone Easyhaler with charcoal

• Seretide Diskus

• Seretide Diskus with charcoal

Locations

Country	Name	City	State
Finland	Orion Pharma pharmacology Unit	Espoo

Sponsors (1)

Lead Sponsor	Collaborator
Orion Corporation, Orion Pharma

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cmax of plasma salmeterol and fluticasone propionate		0 hour to 34 hours after study treatment administration
Primary	AUCt of plasma salmeterol and fluticasone propionate		0 hour to 34 hours after study treatment administration