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Study of Mometasone Furoate/Formoterol Fumarate Inhalation Combination in Healthy Volunteers
This study has been completed.
Study NCT00418509   Information provided by Novartis
First Received: January 4, 2007   Last Updated: June 21, 2007   History of Changes

January 4, 2007
June 21, 2007
November 2006
 
Dosage form and dose proportionality of mometasone and formoterol from combination metered dose inhalers (MDI).
Same as current
Complete list of historical versions of study NCT00418509 on ClinicalTrials.gov Archive Site
  • Extrapulmonary (systemic) effects and safety of mometasone and formoterol from combination MDI formulations.
  • Plasma and urine concentrations mometasone and formoterol
Same as current
 
Study of Mometasone Furoate/Formoterol Fumarate Inhalation Combination in Healthy Volunteers
A Randomized, Single Dose, 3-Period Crossover Study to Evaluate the Dosage Form Proportionality, Dose Proportionality and Pharmacokinetics of Mometasone Furoate and Formoterol Fumarate From Three Combination MDI Formulations

This study will compare the performance of three combination metered dose inhalation devices and the variability of mometasone and formoterol doses delivered to the lungs in a healthy volunteer population

 
Phase I
Interventional
Treatment, Randomized, Open Label, Uncontrolled, Crossover Assignment, Pharmacokinetics Study
Healthy
  • Drug: Mometasone furoate
  • Drug: Formoterol fumarate
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
24
 
 

Inclusion Criteria:

  • Healthy, male or female subjects age 18 to 65 years of age (included)
  • In good health as confirmed by past medical history
  • Female subjects must be either surgically sterilized at least 6 months prior to study participation or post-menopausal (no regular menstrual bleeding for at least 2 years)
  • Body mass index (BMI) within the range of 18.5 to 32 kg/m2 and weigh at least 50 kg
  • Able to communicate well with the investigator, to understand and comply with the requirements of the study
  • Understand and sign the written informed consent

Exclusion Criteria:

  • Smokers (use of tobacco products in the previous 1 year with a pack year history of no greater than 10 pack years).
  • Female subjects who are pregnant, or lactating
  • Treatment with any oral or intravenous corticosteroids within 1 month of the first study treatment.
  • Patients with a current respiratory tract infection or one within 1 month prior to screening.
  • Patients with a history of malignancy, myocardial infarction, untoward reactions to sympathomimetic amines or inhaled medicine.

Subjects with a current or history of a clinically significant cardiac arrhythmia.

  • Participation in any clinical investigation within 4 weeks prior to dosing or longer if required by local regulation.
  • Donation or loss of 400 mL or more of blood within 8 weeks prior to dosing.
  • Significant illness within the two weeks prior to dosing.
  • A past medical history of clinically significant ECG abnormalities.
  • History of fainting, known hypersensitivity to the study drug or drugs similar to the study drug. any surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of drugs or which may jeopardize the subject in case of participation in the study, immunocompromise, including a positive HIV (ELISA and Western blot) test result, positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result, drug or alcohol abuse within the 12 months prior to dosing or evidence of such abuse as indicated by the laboratory assays conducted during the screening evaluations.

Other protocol-defined inclusion/exclusion criteria may apply

Both
18 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT00418509
 
CFOR258H2104
Novartis
Schering-Plough
Principal Investigator: Novartis Investigator site
Novartis
June 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP