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Phase I Pharmacokinetic Study (BF-BLOCK)

NCT01423305 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2011-10-21

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Budesonide/formoterol capsule.

Oral administration with concomitant charcoal.

DRUG

Budesonide/formoterol capsule for oral adm.

Oral administration without concomitant charcoal.

Sponsors & Collaborators

  • Orion Corporation, Orion Pharma

    lead INDUSTRY

Principal Investigators

  • Mika Scheinin, M.D.Ph.D · Clinical Research Services Turku Finland

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-08-31
Primary Completion
2011-10-31
Completion
2011-10-31

Countries

  • Finland

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01423305 on ClinicalTrials.gov