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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
History of Changes

August 23, 2011
October 20, 2011
August 2011
October 2011   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01423305 on ClinicalTrials.gov Archive Site
  • Pharmacokinetic variables [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Cmax
  • Pharmacokinetic variable [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    tmax
Same as current
Not Provided
Not Provided
 
Phase I Pharmacokinetic Study (BF-BLOCK)
Effect of Charcoal on Gastrointestinal Absorption of Budesonide and Formoterol

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.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Asthma
  • Drug: Budesonide/formoterol capsule.
    Oral administration with concomitant charcoal.
  • Drug: Budesonide/formoterol capsule for oral adm.
    Oral administration without concomitant charcoal.
  • Experimental: Treatment A
    Budesonide/formoterol capsule (Orion Pharma) for oral administration.
    Intervention: Drug: Budesonide/formoterol capsule.
  • Experimental: Treatment B
    Budesonide/formoterol capsule (Orion Pharma) for oral administration.
    Intervention: Drug: Budesonide/formoterol capsule for oral adm.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
October 2011
October 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years to 60 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Finland
 
NCT01423305
3103008
No
Orion Corporation, Orion Pharma
Orion Corporation, Orion Pharma
Not Provided
Principal Investigator: Mika Scheinin, M.D.Ph.D Clinical Research Services Turku Finland
Orion Corporation, Orion Pharma
October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP