Drug Interaction Study of Safinamide and a BCRP Substrate, Diclofenac, Concomitantly Administered to Healthy Volunteers
Completed
Cross Research S.A.
Phase 1
2015-05-01
To evaluate if a single dose of safinamide 200 mg has an effect on the pharmacokinetics of
diclofenamic acid, concomitantly administered as a single 50 mg diclofenac sodium dose, with
respect to 50 mg diclofenac sodium administered alone.
Drug Interaction Study of Safinamide and a BCRP Substrate, Diclofenac, Concomitantly Administered to Healthy Volunteers
Completed
Zambon SpA
Phase 1
2015-05-01
To evaluate if a single dose of safinamide 200 mg has an effect on the pharmacokinetics of
diclofenamic acid, concomitantly administered as a single 50 mg diclofenac sodium dose, with
respect to 50 mg diclofenac sodium administered alone.
Safinamide Steady State Interaction With Rosuvastatin
Completed
Zambon SpA
Phase 1
2017-05-22
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.
Safinamide Steady State Interaction With Rosuvastatin
Completed
Cross Research S.A.
Phase 1
2017-05-22
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.
The study is a placebo controlled study, with two parallel arms, in which participants will
be randomly assigned in a 2:1 ratio to receive either active (200 mg safinamide) or placebo
in a double blind manner. Study population is patients diagnosed, with possible or probable
parkinsonian variant of Multiple System Atrophy who are on a stable treatment of levodopa
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