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Bioequivalence Study of Budesonide/Formoterol Easyhaler and Symbicort Turbohaler in Asthmatics

NCT00964535 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 87

Last updated 2010-02-15

No results posted yet for this study

Summary

The purpose of this study is to compare the test product Budesonide/formoterol Easyhaler with the marketed product Symbicort Turbohaler in terms of the drug absorbed into the bloodstream.

Conditions

Interventions

DRUG

budesonide and formoterol 200/6 microg

2 inhalations as a single dose

DRUG

budesonide and formoterol 200/6 microg

2 inhalations as a single dose

DRUG

budesonide and formoterol 200/6 microg

2 inhalations as a single dose with the concurrent charcoal blockage

DRUG

budesonide and formoterol 200/6 microg

2 inhalations as a single dose with the concurrent charcoal blockage

Sponsors & Collaborators

  • Orion Corporation, Orion Pharma

    lead INDUSTRY

Principal Investigators

  • Ulla Sairanen, MSc · Orion Corporation, Orion Pharma

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-09-30
Primary Completion
2010-02-28
Completion
2010-02-28

Countries

  • United Kingdom

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 NCT00964535 on ClinicalTrials.gov