Healthy Clinical Trial
Official title:
Drug Interaction Study of Safinamide and a BCRP Substrate, Rosuvastatin, Concomitantly Administered to Healthy Volunteers
To evaluate if safinamide at the steady state, obtained after multiple 100 mg once a day administrations, has an effect on the pharmacokinetics of rosuvastatin, concomitantly administered as a single 20 mg dose, with respect to the pharmacokinetics of 20 mg rosuvastatin administered alone.
Xadago® SmPC reports that safinamide may transiently inhibit BCRP, therefore a time interval
of 5 h should be kept between dosing of safinamide and medicinal products that are BCRP
substrates with a Tmax ≤ 2 h (e.g. pitavastatin, pravastatin, ciprofloxacin, methotrexate,
topotecan, diclofenac or glyburide).
Following a specific request of FDA, the present interaction study in healthy male and female
volunteers will be conducted in order to determine if multiple dose administration of
safinamide with the BCRP substrate rosuvastatin alters the plasma exposure of rosuvastatin in
vivo. Orally administered rosuvastatin, a 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA)
reductase inhibitor, developed for the treatment of dyslipidaemia, represents a sensitive
probe to assess the magnitude of BCRP inhibition. In PK trials in healthy volunteers,
rosuvastatin Tmax ranged from 1.7 to 5 h after administration of 10-80 mg doses.
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