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Completed

NCT Number: NCT01423305

Phase I Pharmacokinetic Study (BF-BLOCK)

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.

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Clinical Reseach Services Turku (CRST)

Turku, 20520, Finland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy males and females aged 18-60 years.
  • 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 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.
  • Any condition requiring concomitant treatment (including vitamins and herbal products) or likely to need any concomitant treatment during the study.
  • Known hypersensitivity to the active substance(s) or the excipients of the drug.
  • Pregnant or lactating females.

Treatment and study plan

Budesonide/formoterol capsule.

Drug

Oral administration with concomitant charcoal.

Budesonide/formoterol capsule for oral adm.

Drug

Oral administration without concomitant charcoal.

Primary outcomes

  1. The evaluation of primary pharmacokinetic variable AUCt

    Time frame: 4 weeks

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

Secondary outcomes

  1. Pharmacokinetic variables

    Time frame: 4 weeks

    Cmax

  2. Pharmacokinetic variable

    Time frame: 4 weeks

    tmax

Sponsors and collaborators

Lead sponsor

Orion Corporation, Orion Pharma

Industry

Registry information

Official study title

Effect of Charcoal on Gastrointestinal Absorption of Budesonide and Formoterol

Acronym: BF-BLOCK

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Aug 25, 2011
Registry last updated
Oct 21, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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