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Riluzole Orodispersible Film Replicate Bioavailability

NCT04819438 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2025-05-02

Study results available
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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.

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.

Sponsors & Collaborators

  • Zambon SpA

    collaborator INDUSTRY

  • Cross Research S.A.

    lead INDUSTRY

Principal Investigators

  • Milko Radicioni, MD · CROSS Research SA

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

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

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04819438 on ClinicalTrials.gov