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Randomised, 2-Sequence, 4-Period Replicate Cross-Over Bioequivalence Study of A New Riluzole Orodispersible Film Vs. A Reference Tablet in Healthy Volunteers

Purpose: The present bioequivalence study aimed at demonstrating the bioequivalence of a recently developed novel riluzole orodispersible film vs. a reference tablet. Methods: Healthy male and female volunteers received single oral doses of 50 mg of riluzole, as test and reference formulation, under fasting conditions, in each of 4 subsequent periods separated by wash-out intervals of at least 7 days, according to a 2-treatment, 4-period, replicate randomised cross-over design. Findings: Riluzole plasma concentrations were almost superimposable. Riluzole attained a similar peak concentration (315.62±124.95 ng/mL with the film and 278.81±123.32 ng/mL with the tablet) at a median tmax of 0.75 h after both treatments. Then, riluzole plasma concentrations showed a superimposable decline from the peak up to 36 h post-dose, with mean half-lives of 10.22±1.66 and 10.22±1.48 h with the film and the tablet. Mean AUC0-t was 1263.40±571.58 h*ng/mL with the film and 1135.98±514.98 h*ng/mL with the tablet. The 90% confidence intervals of Cmax, AUC0-t and AUC0-¥ of riluzole fell within the predefined range 80.00-125.00%. The treatments did not differ significantly either in tmax or t1/2. On average, the test orodispersible film dissolved on the tongue in a median time of about 2.5 min with a range of 0.7-5.7 min. Orodispersible film palatability was good or acceptable for most subjects.
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