Riluzole Orodispersible Film Replicate Bioavailability

PHASE1CompletedINTERVENTIONAL
Enrollment

54

Participants

Timeline

Start Date

January 15, 2021

Primary Completion Date

March 14, 2021

Study Completion Date

March 14, 2021

Conditions
Healthy Participants
Interventions
DRUG

Riluzole 50 mg orodispersible film

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.

DRUG

Rilutek® 50 mg riluzole tablets

One film-coated tablet will be swallowed (without chewing) with 150 mL of still mineral water.

Trial Locations (1)

6864

CROSS Research SA Phase 1 Unit, Arzo

Sponsors
All Listed Sponsors
collaborator

Zambon SpA

INDUSTRY

lead

Cross Research S.A.

INDUSTRY