Pharmacokinetic Pilot Study on Budesonide/Formoterol Device-metered Dry Powder Inhaler, Symbicort Turbuhaler; an Open, Single Center, Single Dose Study With 3-way Crossover Design in Healthy Subjects

Orion Corporation, Orion Pharma1 site in 1 country12 target enrollmentApril 2009

ConditionsHealthy

InterventionsBudesonide/Formoterol Batch 1 Budesonide/Formoterol Batch 2 Budesonide/Formoterol Batch 1 and charcoal

DrugsBudesonide/Formoterol Batch 1 Budesonide/Formoterol Batch 2 Budesonide/Formoterol Batch 1 and charcoal

Overview

Phase: Phase 1
Intervention: Budesonide/Formoterol Batch 1
Conditions: Healthy
Sponsor: Orion Corporation, Orion Pharma
Enrollment: 12
Locations: 1
Primary Endpoint: Assess the methodology, practical arrangements and pulmonary absorption with charcoal blockage
Status: Completed
Last Updated: 16 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The aim of this pilot study is to assess the methodology, practical arrangements and pulmonary absorption with charcoal blockage for the future bioequivalence studies. In addition, PK of budesonide and formoterol after administration from 2 different batches of Symbicort TH is compared with each other.

Registry

clinicaltrials.gov

Start Date

April 2009

End Date

May 2009

Last Updated

16 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Orion Corporation, Orion Pharma

Eligibility Criteria

Inclusion Criteria

•Good general health ascertained by detailed medical history, and laboratory and physical examinations
•Finnish speaking males and females, 18-55 (inclusive) years of age
•Normal weight defined as body mass index (BMI) \> 19 and \< 30 kg/m2
•Weight at least 50 kg
•Regular intestinal transit

Exclusion Criteria

•Evidence of a clinically significant cardiovascular, renal, hepatic, haematological, gastrointestinal, pulmonary, metabolic-endocrine, neurological or psychiatric disease
•Any abnormal value of laboratory, vital signs, 12-lead electrocardiogram or physical exam which may in the opinion of the investigator interfere with the test results or cause a health risk for the subject if he/she takes part into the study
•Any condition requiring regular concomitant treatment (including vitamins and herbal products) or likely to need any concomitant treatment during the study
•Known hypersensitivity to the active substance(s) or to any of the excipients of the drug
•Pregnant or lactating females
•Recent or current (suspected) drug abuse or positive result in the drugs abuse test
•Recent or current alcohol abuse (regular drinking more than 21 units per week for males and more than 16 units per week for females \[1 unit = 4 cl spirits or equivalent\])
•Current use of nicotine containing products more than 5 cigarettes (or equivalent)/day and/or inability to refrain from the use of nicotine containing products during the study
•Use of caffeine containing beverages more than 600 mg of caffeine/day and/or inability to refrain from the use of caffeine containing beverages during the treatment periods until 24 h after study treatment administration
•Blood donation or loss of significant amount of blood within 90 days prior to the first study treatment administration