Pharmacokinetic Pilot Study on Budesonide/Formoterol Device-metered Dry Powder Inhaler

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Budesonide/Formoterol Batch 1; Drug: Budesonide/Formoterol Batch 2; Drug: Budesonide/Formoterol Batch 1 and charcoal

• Registration Number: NCT00868426
• Lead Sponsor: Orion Corporation, Orion Pharma

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-03-24
• Study First Submitted QC: 2009-03-24
• Study First Posted: 2009-03-25
• Study Start: 2009-04
• Primary Completion: 2009-05
• Study Completion: 2009-05
• Status Verified: 2009-07
• Last Update Submitted: 2009-08-12
• Last Update Posted: 2009-08-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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

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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
• Administration of another investigational drug within 90 days prior to the first study treatment administration
• Unsuitable veins for repeated venipuncture or for cannulation
• Inability to learn the correct inhalation technique
• Inability to participate in all treatment periods

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1	Budesonide/Formoterol Batch 1	Budesonide/Formoterol Batch 1
2	Budesonide/Formoterol Batch 2	Budesonide/Formoterol Batch 2
3	Budesonide/Formoterol Batch 1 and charcoal	Budesonide/Formoterol Batch 1 and charcoal

Primary Outcome Measures

Name	Time	Method
Assess the methodology, practical arrangements and pulmonary absorption with charcoal blockage	1 day

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics of budesonide and formoterol after administration of two different batches of Symbicort Turbuhaler	1 day

Trial Locations

Locations (1)

Orion Pharma Phase I Unit; 🇫🇮 Espoo, Finland