Riluzole Orodispersible Film Replicate Bioavailability
Status:
Completed
Trial end date:
2021-03-14
Target enrollment:
Participant gender:
Summary
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.