Comparison of Budesonide and Formoterol Absorption From Budesonide/Formoterol Easyhaler and Symbicort Turbuhaler

Orion Pharma

Status and phase: Completed; Phase 1

Conditions: Asthma

Treatments: Drug: Symbicort Turbuhaler forte; Drug: Budesonide/formoterol Easyhaler 320/9 microg

Study type: Interventional

Funder types: Industry

Identifiers

NCT01386996

3103004

Details and patient eligibility

About

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

Enrollment: 74 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

1. Healthy males and females aged 18-60 years.
2. Normal weight, at least 50 kg.

Exclusion criteria

1. Evidence of a clinically significant cardiovascular, renal, hepatic, haematological, GI, pulmonary, metabolic-endocrine, neurological or psychiatric disease.
2. Any clinically significant abnormal laboratory value or physical finding that may interfere with the interpretation of study results or constitute a health risk for the subject if he/she takes part in the study.
3. Any condition requiring regular concomitant treatment (including vitamins and herbal products) or likely to need any concomitant treatment during the study.
4. Known hypersensitivity to the active substance(s) or the excipient of the drug.
5. Pregnant or lactating females.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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74 participants in 4 patient groups

Charcoal and Budesonide/formoterol Easyhaler

Experimental group

Treatment:

Drug: Budesonide/formoterol Easyhaler 320/9 microg

Charcoal and Symbicort Turbuhaler

Active Comparator group

Treatment:

Drug: Symbicort Turbuhaler forte

Budesonide/formoterol Easyhaler

Experimental group

Treatment:

Drug: Budesonide/formoterol Easyhaler 320/9 microg

Symbicort Turbuhaler

Active Comparator group

Treatment:

Drug: Symbicort Turbuhaler forte