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

Orion Pharma

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: Budesonide/Formoterol Batch 1

Drug: Budesonide/Formoterol Batch 2

Drug: Budesonide/Formoterol Batch 1 and charcoal

Study type

Interventional

Funder types

Industry

Identifiers

NCT00868426

3103001

Details and patient eligibility

About

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.

Enrollment

12 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

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
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