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amantadine

Phase 1

Healthy | Small molecule | Other |Novartis AG|Last Updated: Nov 30, 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 Enrollment18
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00416962Safety and Pharmacokinetic Effects of Oseltamivir Alone or in Combination With AmantadinePHASE1 COMPLETED 18 — — Aug 1, 2006Dec 1, 2006Nov 30, 20071 United States
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Study Endpoints
Primary Endpoints
To characterize the pharmacokinetics of amantadine following twice daily administration alone or in combination with twice daily oseltamivir in healthy volunteers.
To characterize the pharmacokinetics of oseltamivir following twice daily administration alone or in combination with twice daily amantadine in healthy volunteers.
Secondary Endpoints
To assess the safety and tolerability of twice daily oseltamivir and twice daily amantadine when given alone and when given in combination.
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT
Interventions
NameTypeDescription
amantadine hydrochlorideDRUG -
oseltamivir phosphateDRUG -
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Eligibility Criteria
Age Range18 Years — 45 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy male or female subjects aged 18 to 45 years, and in good health as determined by past medical history, physical examination, vital signs, electrocardiogram, and laboratory tests * Vital signs within the following ranges: * oral body temperature 35.0 - 37.5°C * sys...

Countries:United States
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