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drugset / Trial / NCT04819438

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

Outcome

Met primary endpoint

registry analysis (equivalence test); Riluzole Orodispersible Film (Test) vs Rilutek® Tablet (Reference); p <0.0001; Geometric Mean Ratio 117.05 (90% CI 110.43 to 124.06); ANOVA NCT04819438 ↗

registry analysis (equivalence test); Riluzole Orodispersible Film (Test) vs Rilutek® Tablet (Reference); p <0.0001; Geometric Mean Ratio 111.82 (90% CI 108.25 to 115.50); ANOVA NCT04819438 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Riluzole Small molecule 50 mg Oral

Indications

No indication recorded.