Pharmacokinetic Pilot Study on Budesonide/Formoterol

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