Pharmacokinetic Study Comparing Budesonide/Formoterol Easyhaler and Symbicort Turbuhaler Forte

Pharmacokinetic Study Comparing Budesonide/Formoterol Easyhaler and Symbicort Turbuhaler Forte; a Randomised, Double-blind, Double-dummy, Single Centre, Single Dose, Crossover Study in Healthy Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01627158

Acronym

ADECO

Enrollment

Registered

2012-06-25

Start date

2012-06-30

Completion date

2012-10-31

Last updated

2012-10-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma

Brief summary

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.

Interventions

DRUGBudesonide/formoterol Easyhaler

Budesonide/formoterol Easyhaler

DRUGSymbicort Turbuhaler

Symbicort Turbuhaler

DRUGCharcoal and Budesonide/formoterol Easyhaler

Charcoal and Budesonide/formoterol Easyhaler

DRUGCharcoal and Symbicort Turbuhaler

Charcoal and Symbicort Turbuhaler

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
Pharmacokinetic parameter AUCt of plasma formoterol concentration	24 h
Pharmacokinetic parameter Cmax of plasma budesonide concentration	within 12 h
Pharmacokinetic parameter AUCt of plasma budesonide concentration	12 h
Pharmacokinetic parameter Cmax of plasma formoterol concentration	24 h

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026