Bioavailability and Pharmacokinetics of Once-Daily Amantadine Extended-Release Tablets in Healthy Volunteers: Results from Three Randomized, Crossover, Open-Label, Phase 1 Studies

Neurology and Therapy
Tina deVriesDavid Jacobs

Abstract

In February 2018, OS320-an amantadine extended-release (ER) tablet formulation with once-daily morning administration-was approved for the treatment of Parkinson's disease and drug-induced extrapyramidal reactions in adults. The purpose of this study was to describe three phase 1 studies that assessed the pharmacokinetics (PK) and bioavailability of amantadine ER in healthy adult volunteers. Study 1 was an open-label, four-treatment, single-dose, crossover study comparing amantadine ER 129, 193, and 258 mg tablets with an equivalent dose of immediate-release (IR) amantadine 40 mg/5 mL syrup. Study 2 was an open-label, single-dose, crossover food-effect study with amantadine ER 258 mg. Study 3 was an open-label, multiple-dose, crossover study comparing amantadine ER and amantadine IR syrup. Amantadine ER displayed a steady release of amantadine, with the peak amantadine concentration occurring at ~ 7.5 h postdose or in the middle of the day (following a morning dose) with steady-state administration. Administration of amantadine ER 258 mg with a high-fat meal did not affect amantadine bioavailability. Amantadine plasma exposure increased proportionally with increasing doses, and at steady state, amantadine exposure from an amant...Continue Reading

References

Jan 1, 1988·Clinical Pharmacokinetics·F Y Aoki, D S Sitar
May 30, 1970·Lancet·J D ParkesR P Knill-Jones
Dec 1, 1994·The Journal of Adolescent Health : Official Publication of the Society for Adolescent Medicine·C V FletcherJ M Strykowski
Oct 14, 2006·Therapeutic Drug Monitoring·Johannes KornhuberIngolf Meineke
Feb 5, 2010·PM & R : the Journal of Injury, Function, and Rehabilitation·Jilda N Vargus-AdamsAlexander A Vinks
Aug 9, 2018·The Journal of Pharmacology and Experimental Therapeutics·Elizabeth F BrighamJack T Nguyen

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Citations

Feb 25, 2021·Journal of Neural Transmission·Wojciech DanyszPeter Riederer
Oct 15, 2021·CNS Drugs·Sarah MarmolJason Margolesky

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