Phase I Pharmacokinetic Study (BF-BLOCK)

Orion Pharma

Status and phase: Completed; Phase 1

Conditions: Asthma

Treatments: Drug: Budesonide/formoterol capsule.; Drug: Budesonide/formoterol capsule for oral adm.

Study type: Interventional

Funder types: Industry

Identifiers

NCT01423305

3103008

Details and patient eligibility

About

The objective of the study is to assess if charcoal prevents the absorption of budesonide and formoterol via GI track. The assessment will be based on comparing the pharmacokinetic parameter area under the concentration-time curve.

Enrollment: 20 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Healthy males and females aged 18-60 years.
2. Normal weight at least 50 kg.

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Treatment A

Experimental group

Description:

Budesonide/formoterol capsule (Orion Pharma) for oral administration.

Treatment:

Drug: Budesonide/formoterol capsule.

Treatment B

Experimental group

Description:

Budesonide/formoterol capsule (Orion Pharma) for oral administration.

Treatment:

Drug: Budesonide/formoterol capsule for oral adm.