Riluzole Orodispersible Film Replicate Bioavailability

NCT04819438 ↗

Phase 1 Completed 54 enrolled Cross Research S.A. Zambon SpA · collab

RandomizedCrossoverOpen-labelTreatment

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.

Timeline

Start: 2021-01-15
Primary completion: 2021-03-14
Completion: 2021-03-14

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Riluzole	Small molecule	50 mg	Oral

Indications

No indication recorded.