While several generic preparations of levodopa/carbidopa and levodopa/benserazide (LBD) are currently available, pharmacokinetic (PK) equivalence and therapeutic equivalence studies with levodopa generics are not available in Italy. Lack of data on generic formulations is a critical factor for their limited use in this country and often lead patients to refuse the generic version of the branded drug.

Clinical and pharmacokinetics equivalence of multiple doses of levodopa benserazide generic formulation vs the originator (Madopar)

Bonassi, Stefano;Stocchi, Fabrizio
2019-01-01

Abstract

While several generic preparations of levodopa/carbidopa and levodopa/benserazide (LBD) are currently available, pharmacokinetic (PK) equivalence and therapeutic equivalence studies with levodopa generics are not available in Italy. Lack of data on generic formulations is a critical factor for their limited use in this country and often lead patients to refuse the generic version of the branded drug.
2019
generic formulation
noninferiority
originator
pharmacokinetic equivalence
Adult
Aged
Benserazide
Cross-Over Studies
Dopamine Agents
Double-Blind Method
Drug Combinations
Drugs, Generic
Humans
Levodopa
Male
Middle Aged
Parkinson Disease
Severity of Illness Index
Treatment Outcome
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/20.500.12078/7623
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