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Phase I Pharmacokinetic Study (BF-BLOCK)

NCT ID: NCT01423305

Last Updated: 2011-10-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-31

Study Completion Date

2011-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment A

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

Group Type EXPERIMENTAL

Budesonide/formoterol capsule.

Intervention Type DRUG

Oral administration with concomitant charcoal.

Treatment B

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

Group Type EXPERIMENTAL

Budesonide/formoterol capsule for oral adm.

Intervention Type DRUG

Oral administration without concomitant charcoal.

Interventions

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Budesonide/formoterol capsule.

Oral administration with concomitant charcoal.

Intervention Type DRUG

Budesonide/formoterol capsule for oral adm.

Oral administration without concomitant charcoal.

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Orion Corporation, Orion Pharma

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mika Scheinin, M.D.Ph.D

Role: PRINCIPAL_INVESTIGATOR

Clinical Research Services Turku Finland

Locations

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Clinical Reseach Services Turku (CRST)

Turku, , Finland

Site Status

Countries

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Finland

Other Identifiers

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3103008

Identifier Type: -

Identifier Source: org_study_id