Riluzole Orodispersible Film Replicate Bioavailability

Autores
Categoría Estudio primario
Registro de estudiosclinicaltrials.gov
Año 2021

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The objective of the study is to compare the pharmacokinetic profile of riluzole after replicate single dose of the novel orodispersible film test formulation and of the marketed reference Rilutek® tablets and to evaluate their bioequivalence.

The subjects will receive single oral doses of 50 mg of riluzole, as test orodispersible film and reference film-coated tablets under fasting conditions, in each of 4 subsequent periods separated by wash-out intervals of at least 7 days between consecutive administrations, according to a 2-treatment, 4-period, replicate cross-over design.
Epistemonikos ID: f6ae70e94611ee72d7b3c0a8292e6d52b777e2e2
First added on: May 08, 2024