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

O

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

Trial design

12 participants in 3 patient groups

1
Experimental group
Description:
Budesonide/Formoterol Batch 1
Treatment:
Drug: Budesonide/Formoterol Batch 1
2
Experimental group
Description:
Budesonide/Formoterol Batch 2
Treatment:
Drug: Budesonide/Formoterol Batch 2
3
Experimental group
Description:
Budesonide/Formoterol Batch 1 and charcoal
Treatment:
Drug: Budesonide/Formoterol Batch 1 and charcoal

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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