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

O

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

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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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