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Pharmacokinetic Pilot Study on Budesonide/Formoterol Device-metered Dry Powder Inhaler

NCT00868426 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2009-08-13

No results posted yet for this study

Summary

The aim of this pilot study is to assess the methodology, practical arrangements and pulmonary absorption with charcoal blockage for the future bioequivalence studies. In addition, PK of budesonide and formoterol after administration from 2 different batches of Symbicort TH is compared with each other.

Conditions

  • Healthy

Interventions

DRUG

Budesonide/Formoterol Batch 1

Single, inhaled dose

DRUG

Budesonide/Formoterol Batch 2

Single, inhaled dose

DRUG

Budesonide/Formoterol Batch 1 and charcoal

Single, inhaled dose

Sponsors & Collaborators

  • Orion Corporation, Orion Pharma

    lead INDUSTRY

Principal Investigators

  • Kimmo Ingman, MD, PhD · Orion Corporation, Orion Pharma

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2009-04-30
Primary Completion
2009-05-31
Completion
2009-05-31

Countries

  • Finland

Study Locations

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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 NCT00868426 on ClinicalTrials.gov