Phase I Pharmacokinetic Study (BF-BLOCK)

Asthma Clinical Trial

— BF-BLOCK  

Official title:

Effect of Charcoal on Gastrointestinal Absorption of Budesonide and Formoterol

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01423305
• Other study ID #: 3103008
• Status: Completed
• Phase: Phase 1
• First received: August 23, 2011
• Last updated: October 20, 2011
• Start date: August 2011
• Est. completion date: October 2011

Study information

• Verified date: October 2011
• Source: Orion Corporation, Orion Pharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Finnish Medicines Agency
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• Budesonide/formoterol capsule.
Oral administration with concomitant charcoal.
• Budesonide/formoterol capsule for oral adm.
Oral administration without concomitant charcoal.

Locations

Country	Name	City	State
Finland	Clinical Reseach Services Turku (CRST)	Turku

Sponsors (1)

Lead Sponsor	Collaborator
Orion Corporation, Orion Pharma

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	4 weeks	No
Secondary	Pharmacokinetic variables	Cmax	4 weeks	No
Secondary	Pharmacokinetic variable	tmax	4 weeks	No