Study of Mometasone Furoate/Formoterol Fumarate Inhalation Combination in Healthy Volunteers

Study Overview
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Brief Summary
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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

Official Title
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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

Conditions
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Healthy

Intervention / Treatment
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* Drug: Mometasone furoate
* Drug: Formoterol fumarate


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Mometasone furoate|nan|
|Drug: Formoterol fumarate|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dosage form and dose proportionality of mometasone and formoterol from combination metered dose inhalers (MDI). |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Extrapulmonary (systemic) effects and safety of mometasone and formoterol from combination MDI formulations. |  |  | 
| Plasma and urine concentrations mometasone and formoterol |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dose proportionality, pharmacokinetics, mometasone, formoterol, Healthy volunteers study