Study of Mometasone Furoate/Formoterol Fumarate Inhalation Combination in Healthy Volunteers
This study has been completed.
Information provided by:
First received: January 4, 2007
Last updated: June 21, 2007
Last verified: June 2007
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
|Study Design:||Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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|
Resource links provided by NLM:
Drug Information available for: Formic acid Formoterol fumarate Formoterol Mometasone furoate Mometasone furoate monohydrate Arformoterol TartrateU.S. FDA Resources
Further study details as provided by Novartis:
Primary Outcome Measures:
- Dosage form and dose proportionality of mometasone and formoterol from combination metered dose inhalers (MDI).
Secondary Outcome Measures:
- Extrapulmonary (systemic) effects and safety of mometasone and formoterol from combination MDI formulations.
- Plasma and urine concentrations mometasone and formoterol
|Study Start Date:||November 2006|
Contacts and Locations