Pharmacokinetic Study Comparing Budesonide/Formoterol Easyhaler and Symbicort Turbuhaler Forte (ADECO)

Orion Pharma

Status and phase: Completed; Phase 1

Conditions: Asthma

Treatments: Drug: Symbicort Turbuhaler; Drug: Charcoal and Budesonide/formoterol Easyhaler; Drug: Budesonide/formoterol Easyhaler; Drug: Charcoal and Symbicort Turbuhaler

Study type: Interventional

Funder types: Industry

Identifiers

NCT01627158

3103011

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: 72 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Written informed consent (IC) obtained.
2. Males and females, 18-60 (inclusive) years of age.

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: Double Blind

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72 participants in 4 patient groups

Budesonide/formoterol Easyhaler

Experimental group

Description:

Budesonide/formoterol Easyhaler

Treatment:

Drug: Budesonide/formoterol Easyhaler

Symbicort Turbuhaler

Active Comparator group

Description:

Symbicort Turbuhaler

Treatment:

Drug: Symbicort Turbuhaler

Charcoal and Budesonide/formoterol Easyhaler

Experimental group

Treatment:

Drug: Charcoal and Budesonide/formoterol Easyhaler

Charcoal and Symbicort Turbuhaler

Active Comparator group

Treatment:

Drug: Charcoal and Symbicort Turbuhaler