NCT00868426

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_1 healthy

Timeline
Completed

Started Apr 2009

Shorter than P25 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 24, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 25, 2009

Completed
7 days until next milestone

Study Start

First participant enrolled

April 1, 2009

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed
Last Updated

August 13, 2009

Status Verified

July 1, 2009

Enrollment Period

1 month

First QC Date

March 24, 2009

Last Update Submit

August 12, 2009

Conditions

Healthy

Keywords

Healthy volunteer study

Outcome Measures

Primary Outcomes (1)

  • Assess the methodology, practical arrangements and pulmonary absorption with charcoal blockage

    1 day

Secondary Outcomes (1)

  • Pharmacokinetics of budesonide and formoterol after administration of two different batches of Symbicort Turbuhaler

    1 day

Study Arms (3)

1

EXPERIMENTAL

Budesonide/Formoterol Batch 1

Drug: Budesonide/Formoterol Batch 1

2

EXPERIMENTAL

Budesonide/Formoterol Batch 2

Drug: Budesonide/Formoterol Batch 2

3

EXPERIMENTAL

Budesonide/Formoterol Batch 1 and charcoal

Drug: Budesonide/Formoterol Batch 1 and charcoal

Interventions

Budesonide/Formoterol Batch 1DRUG

Single, inhaled dose

Also known as: Symbicort Turbuhaler
1
Budesonide/Formoterol Batch 2DRUG

Single, inhaled dose

Also known as: Symbicort Turbuhaler
2
Budesonide/Formoterol Batch 1 and charcoalDRUG

Single, inhaled dose

Also known as: Symbicort Turbuhaler
3

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Good general health ascertained by detailed medical history, and laboratory and physical examinations
  • Finnish speaking males and females, 18-55 (inclusive) years of age
  • Normal weight defined as body mass index (BMI) \> 19 and \< 30 kg/m2
  • Weight at least 50 kg
  • Regular intestinal transit

You may not qualify if:

  • Evidence of a clinically significant cardiovascular, renal, hepatic, haematological, gastrointestinal, pulmonary, metabolic-endocrine, neurological or psychiatric disease
  • Any abnormal value of laboratory, vital signs, 12-lead electrocardiogram or physical exam which may in the opinion of the investigator interfere with the test results or cause a health risk for the subject if he/she takes part into the study
  • Any condition requiring regular concomitant treatment (including vitamins and herbal products) or likely to need any concomitant treatment during the study
  • Known hypersensitivity to the active substance(s) or to any of the excipients of the drug
  • Pregnant or lactating females
  • Recent or current (suspected) drug abuse or positive result in the drugs abuse test
  • Recent or current alcohol abuse (regular drinking more than 21 units per week for males and more than 16 units per week for females \[1 unit = 4 cl spirits or equivalent\])
  • Current use of nicotine containing products more than 5 cigarettes (or equivalent)/day and/or inability to refrain from the use of nicotine containing products during the study
  • Use of caffeine containing beverages more than 600 mg of caffeine/day and/or inability to refrain from the use of caffeine containing beverages during the treatment periods until 24 h after study treatment administration
  • Blood donation or loss of significant amount of blood within 90 days prior to the first study treatment administration
  • Administration of another investigational drug within 90 days prior to the first study treatment administration
  • Unsuitable veins for repeated venipuncture or for cannulation
  • Inability to learn the correct inhalation technique
  • Inability to participate in all treatment periods

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Orion Pharma Phase I Unit

Espoo, 02101, Finland

Location

MeSH Terms

Interventions

BudesonideBudesonide, Formoterol Fumarate Drug CombinationCharcoal

Intervention Hierarchy (Ancestors)

PregnenedionesPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsFormoterol FumarateEthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAminesDrug CombinationsPharmaceutical PreparationsCarbonElementsInorganic Chemicals

Study Officials

  • Kimmo Ingman, MD, PhD

    Orion Corporation, Orion Pharma

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 24, 2009

First Posted

March 25, 2009

Study Start

April 1, 2009

Primary Completion

May 1, 2009

Study Completion

May 1, 2009

Last Updated

August 13, 2009

Record last verified: 2009-07

Locations

FI(1)