At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Comparative Bioavailability Study of a New Riluzole Orodispersible Film vs. a Marketed Oral Reference (Rilutek® Tablets) in Healthy Male and Female Volunteers
In Brief
A Phase 1 clinical trial evaluating Riluzole 50 mg orodispersible film and Rilutek® 50 mg riluzole tablets for Healthy Participants. Completed, enrolled 54 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
Before each administration, the subjects will drink 20 mL of still mineral water in order to wet their mouth. Afterwards, using gloves, the investigator or deputy will take the orodispersible film (32.0x22.0 mm) out of the provided pouch and place the product directly on the top surface (dorsal aspect) of the subjects' tongue.
One film-coated tablet will be swallowed (without chewing) with 150 mL of still mineral water.