MedTrace Logo

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

NCT01181063 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2011-06-10

No results posted yet for this study

Summary

Due to the complexity of orally inhaled products (combination of a formulation and a device)and the topical nature of drug delivery to the lung for efficacy in vitro-in vivo correlation(IVIVC) for inhaled dosage forms is not generally known.

The rationale of this pilot study is to gain in vivo data of the Budesonide/formoterol EH product variants under development and compare pulmonary deposition (administration with charcoal) of different product variants of Budesonide/formoterol EH with Symbicort TH.

Conditions

Interventions

DRUG

Budesonide/formoterol 320/9 μg and 400/12 μg inhalers

Budesonide/formoterol 320/9 μg and 400/12 μg in different kind of inhalers and Symbicort Turbuhaler forte 320/9 μg. Ech subject will be randomly allocation to 4 of 5 products, a single dose administration of each product

Sponsors & Collaborators

  • Orion Corporation, Orion Pharma

    lead INDUSTRY

Principal Investigators

  • Kimmo Ingman, MD, PhD · Phase I Unit, Orion Pharma, Espoo, 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
2010-08-31
Primary Completion
2010-10-31
Completion
2010-11-30

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 NCT01181063 on ClinicalTrials.gov