Phase I Pharmacokinetic Study (BF-BLOCK)

Orion Corporation, Orion Pharma20 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Asthma

Interventions

Budesonide/formoterol capsule.DRUG

Oral administration with concomitant charcoal.

Budesonide/formoterol capsule for oral adm.DRUG

Oral administration without concomitant charcoal.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Clinical Reseach Services Turku (CRST)

Turku, Finland

Outcomes

Primary Outcomes

The evaluation of primary pharmacokinetic variable AUCt

The evaluation of primary pharmacokinetic variable AUCt of this study will be based on statistical methods appropriate for crossover design.

Time frame: 4 weeks

Secondary Outcomes

Pharmacokinetic variables

Cmax

Time frame: 4 weeks

Pharmacokinetic variable

tmax

Time frame: 4 weeks

Data from ClinicalTrials.gov

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