Phase I Pharmacokinetic Study (BF-BLOCK)

Phase 1

Completed

• Conditions: Asthma
• Interventions: Drug: Budesonide/formoterol capsule.; Drug: Budesonide/formoterol capsule for oral adm.

• Registration Number: NCT01423305
• Lead Sponsor: Orion Corporation, Orion Pharma

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-08
• Study First Submitted: 2011-08-23
• Study First Submitted QC: 2011-08-24
• Study First Posted: 2011-08-25
• Status Verified: 2011-10
• Primary Completion: 2011-10
• Study Completion: 2011-10
• Last Update Submitted: 2011-10-20
• Last Update Posted: 2011-10-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1. Healthy males and females aged 18-60 years.
2. Normal weight at least 50 kg.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Treatment A	Budesonide/formoterol capsule.	Budesonide/formoterol capsule (Orion Pharma) for oral administration.
Treatment B	Budesonide/formoterol capsule for oral adm.	Budesonide/formoterol capsule (Orion Pharma) for oral administration.

Primary Outcome Measures

Name	Time	Method
The evaluation of primary pharmacokinetic variable AUCt	4 weeks	The evaluation of primary pharmacokinetic variable AUCt of this study will be based on statistical methods appropriate for crossover design.

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetic variables	4 weeks	Cmax
Pharmacokinetic variable	4 weeks	tmax

Trial Locations

Locations (1)

Clinical Reseach Services Turku (CRST); 🇫🇮 Turku, Finland