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

Orion Pharma

Status and phase: Completed; Phase 1

Conditions: Asthma

Treatments: Drug: Budesonide/formoterol; Drug: Symbicort Turbuhaler; Other: Charcoal

Study type: Interventional

Funder types: Industry

Identifiers

NCT03073057

3103014

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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20 participants in 4 patient groups

Charcoal and Budesonide/formoterol Easyhaler A

Experimental group

Description:

160/4.5microg/inhalation Charcoal

Treatment:

Other: Charcoal

Drug: Budesonide/formoterol

Charcoal and Budesonide/formoterol Easyhaler B

Experimental group

Description:

160/4.5microg/inhalation Charcoal

Treatment:

Other: Charcoal

Drug: Budesonide/formoterol

Charcoal and Budesonide/formoterol Easyhaler C

Experimental group

Description:

160/4.5microg/inhalation Charcoal

Treatment:

Other: Charcoal

Drug: Budesonide/formoterol

Charcoal and Symbicort Turbuhaler

Active Comparator group

Description:

160/4.5microg/inhalation Charcoal

Treatment:

Other: Charcoal

Drug: Symbicort Turbuhaler