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amantadine

Phase 1

Healthy | Small molecule | Other |Novartis AG|Last Updated: Nov 30, 2007

Success Probability

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Market & Valuation

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Trial Design

RandomizedUNCONTROLLED
Total Trials1
Total Enrollment18

FDA Designations

No designations recorded

Clinical trial landscape

amantadine · 1 trial · 1 indication

Phase 1 1
NCT00416962Safety and Pharmacokinetic Effects of Oseltamivir Alone or in Combination With AmantadineHealthy
COMPLETED18 Analytics
PHASE1COMPLETED
Safety and Pharmacokinetic Effects of Oseltamivir Alone or in Combination With Amantadine
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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 to 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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Frequently asked questions about amantadine

What is amantadine used for?

Amantadine is a small molecule being studied for use in healthy volunteers. It is currently in Phase 1 clinical development, with one completed trial evaluating its safety and pharmacokinetic effects. The drug is being developed by Novartis AG.

Who makes amantadine?

Amantadine is being developed by Novartis AG, a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol NVS. The company is conducting clinical research on this small molecule drug.

What phase is amantadine in?

Amantadine is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. One Phase 1 trial has been completed, and no active trials are currently listed.

What clinical trials is amantadine in?

Amantadine has been studied in one clinical trial, identified as NCT00416962. This Phase 1 study, titled 'Safety and Pharmacokinetic Effects of Oseltamivir Alone or in Combination With Amantadine,' was completed in the United States with 18 healthy volunteers.

Is amantadine the same as oseltamivir?

No, amantadine is not the same as oseltamivir. They are separate drugs that were studied together in a clinical trial. The trial NCT00416962 evaluated the safety and pharmacokinetic effects of oseltamivir alone or in combination with amantadine in healthy volunteers.