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Mometasone furoate

Phase 1

Healthy | Small molecule | Other |Novartis AG|Last Updated: Jun 22, 2007

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedUNCONTROLLEDBiomarker
Total Trials1
Total Enrollment24
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00418509Study of Mometasone Furoate/Formoterol Fumarate Inhalation Combination in Healthy VolunteersPHASE1 COMPLETED 24Nov 1, 2006 -Jun 22, 20071 United Kingdom
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Study Endpoints
Primary Endpoints
Dosage form and dose proportionality of mometasone and formoterol from combination metered dose inhalers (MDI).
Secondary Endpoints
Extrapulmonary (systemic) effects and safety of mometasone and formoterol from combination MDI formulations.
Plasma and urine concentrations mometasone and formoterol
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT
Interventions
NameTypeDescription
Mometasone furoateDRUG -
Formoterol fumarateDRUG -
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersYes
Study Sites1

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 f...

Countries:United Kingdom
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