Pharmacokinetic Study to Compare Absorption of Budesonide/Formoterol Easyhaler and Symbicort Turbuhaler

Phase 1

Completed

• Conditions: Asthma
• Interventions: Drug: Budesonide/formoterol; Other: Charcoal; Drug: Symbicort Turbuhaler

• Registration Number: NCT03073057
• Lead Sponsor: Orion Corporation, Orion Pharma

Brief Summary

The purpose of this study is to compare Budesonide/formoterol Easyhaler test products with the marketed product Symbicort Turbuhaler in terms of the drug absorbed into the bloodstream.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01
• Status Verified: 2016-02
• Study First Submitted: 2016-02-15
• Primary Completion: 2016-03
• Study Completion: 2016-03
• Study First Submitted QC: 2017-03-02
• Last Update Submitted: 2017-03-02
• Study First Posted: 2017-03-08
• Last Update Posted: 2017-03-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Written informed consent obtained
• Body mass index > 19 and < 30kg/m2, weight at least 50 kg
• 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
• Any condition requiring regular concomitant treatment (including vitamins and herbal products) or likely to need any concomitant treatment during a study.
• Known hypersensitivity to the active substance(s) or the excipient of the drug
• Pregnant and lactating females

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Charcoal and Budesonide/formoterol Easyhaler B	Budesonide/formoterol	160/4.5microg/inhalation Charcoal
Charcoal and Budesonide/formoterol Easyhaler B	Charcoal	160/4.5microg/inhalation Charcoal
Charcoal and Budesonide/formoterol Easyhaler C	Budesonide/formoterol	160/4.5microg/inhalation Charcoal
Charcoal and Budesonide/formoterol Easyhaler C	Charcoal	160/4.5microg/inhalation Charcoal
Charcoal and Symbicort Turbuhaler	Charcoal	160/4.5microg/inhalation Charcoal
Charcoal and Budesonide/formoterol Easyhaler A	Budesonide/formoterol	160/4.5microg/inhalation Charcoal
Charcoal and Budesonide/formoterol Easyhaler A	Charcoal	160/4.5microg/inhalation Charcoal
Charcoal and Symbicort Turbuhaler	Symbicort Turbuhaler	160/4.5microg/inhalation Charcoal

Primary Outcome Measures

Name	Time	Method
AUCt of plasma budesonide and formoterol	within 24 hours
Cmax of plasma budesonide and formoterol	within 24 hours

Trial Locations

Locations (1)

Orion Pharma, Clinical Pharmacology Unit; 🇫🇮 Espoo, Finland