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Pharmacokinetic Pilot Study on Budesonide/Formoterol

O

Orion Pharma

Status

Completed

Conditions

Healthy

Treatments

Drug: Budesonide
Drug: Formoterol
Device: Turbohaler Forte
Device: Easyhaler

Study type

Interventional

Funder types

Industry

Identifiers

NCT01457716
3103007

Details and patient eligibility

About

The aim of the study is to assess and compare the Pharmacokinetic (PK) of Budesonide and Formoterol after administration of 3 different product variants of Budesonide/Formoterol Easyhalers and Symbicort turbuhaler.

Enrollment

17 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Healthy males and females, 18-55 years of age.
  • Normal weight at least 50 kg.

Exclusion criteria

  • Evidence of a clinically significant cardiovascular, renal, hepatic, haematological, gastrointestinal, pulmonary, metabolic-endocrine, neurological or psychiatric disease.
  • Any condition requiring concomitant treatment (including vitamins and herbal products)or likely to need any concomitant treatment during the study
  • Any clinically significant abnormal laboratory value or physical finding that may interfere with the interpretation of test results or cause a health risk for the subject if he/she participates in the study.
  • Known hypersensitivity to the active substance(s) or to any of the excipients of the drug.
  • Pregnant or lactating females.

Trial design

17 participants in 4 patient groups

Budesonide/Formoterol Easyhaler A
Experimental group
Treatment:
Drug: Budesonide
Drug: Formoterol
Device: Easyhaler
Budesonide/Formoterol Easyhaler B
Experimental group
Treatment:
Drug: Budesonide
Drug: Formoterol
Device: Easyhaler
Budesonide/Formoterol Easyhaler C
Experimental group
Treatment:
Drug: Budesonide
Drug: Formoterol
Device: Easyhaler
Budesonide/Formoterol Turbohaler Forte
Active Comparator group
Treatment:
Drug: Budesonide
Device: Turbohaler Forte
Drug: Formoterol

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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