Articles Related to Riluzole
A Case Report of Rapidly Progressing Amyotrophic Lateral Sclerosis in 31 Year Old Patient with Sympathovagal Imbalance
ALS is a fatal neurodegenerative condition characterized by degeneration of upper and lower motor neuron in cerebral cortex, cranial nerve nuclei and anterior horn cells of spinal cord. Three drugs are FDA approved, Riluzole, Edaravone and
AMX0035 (recently approved), which can only prolong survival time by 2-3 months.
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.