Phase I Pharmacokinetic Study (BF-BLOCK)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Orion Corporation, Orion Pharma
ClinicalTrials.gov Identifier:
NCT01423305
First received: August 23, 2011
Last updated: October 20, 2011
Last verified: October 2011
  Purpose

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.


Condition Intervention Phase
Asthma
Drug: Budesonide/formoterol capsule.
Drug: Budesonide/formoterol capsule for oral adm.
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effect of Charcoal on Gastrointestinal Absorption of Budesonide and Formoterol

Resource links provided by NLM:


Further study details as provided by Orion Corporation, Orion Pharma:

Primary Outcome Measures:
  • The evaluation of primary pharmacokinetic variable AUCt [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    The evaluation of primary pharmacokinetic variable AUCt of this study will be based on statistical methods appropriate for crossover design.


Secondary Outcome Measures:
  • Pharmacokinetic variables [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Cmax

  • Pharmacokinetic variable [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    tmax


Enrollment: 20
Study Start Date: August 2011
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment A
Budesonide/formoterol capsule (Orion Pharma) for oral administration.
Drug: Budesonide/formoterol capsule.
Oral administration with concomitant charcoal.
Experimental: Treatment B
Budesonide/formoterol capsule (Orion Pharma) for oral administration.
Drug: Budesonide/formoterol capsule for oral adm.
Oral administration without concomitant charcoal.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01423305

Locations
Finland
Clinical Reseach Services Turku (CRST)
Turku, Finland, 20520
Sponsors and Collaborators
Orion Corporation, Orion Pharma
Investigators
Principal Investigator: Mika Scheinin, M.D.Ph.D Clinical Research Services Turku Finland
  More Information

No publications provided

Responsible Party: Orion Corporation, Orion Pharma
ClinicalTrials.gov Identifier: NCT01423305     History of Changes
Other Study ID Numbers: 3103008
Study First Received: August 23, 2011
Last Updated: October 20, 2011
Health Authority: Finland: Finnish Medicines Agency

Keywords provided by Orion Corporation, Orion Pharma:
Asthma

Additional relevant MeSH terms:
Formoterol
Budesonide
Symbicort
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on September 30, 2014