Pharmacokinetic Study Comparing Salmeterol/Fluticasone Easyhaler Products 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: NCT02162485
• Other study ID #: 3106009
• Status: Completed
• Phase: Phase 1
• First received: June 5, 2014
• Last updated: September 28, 2015
• Start date: June 2014
• Est. completion date: September 2015

Study information

• Verified date: September 2015
• Source: Orion Corporation, Orion Pharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Finnish Medicines Agency, Fimea
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 129
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• 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, 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

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

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		within 34 h	No
Primary	AUCt of plasma salmeterol and fluticasone propionate		34 h	No