Safinamide Steady State Interaction With Rosuvastatin

PHASE1CompletedINTERVENTIONAL
Enrollment

24

Participants

Timeline

Start Date

May 22, 2017

Primary Completion Date

July 6, 2017

Study Completion Date

July 6, 2017

Conditions
Healthy
Interventions
DRUG

100 mg safinamide

"Safinamide will be administered as follows:~* Days 5-11: 100 mg safinamide (one Xadago® tablet), once a day~* Day 12: a single dose of 100 mg safinamide (one Xadago® tablet), immediately followed by a single dose of 20 mg rosuvastatin calcium (one Crestor® tablet)~* Days 13-15: 100 mg safinamide (one Xadago® tablet) once a day The medication will be orally administered in the morning, at 8:00±1h, under fasting conditions, with 240 mL (total volume) of still mineral water."

DRUG

20 mg rosuvastatin calcium period 1

"Rosuvastatin will be administered as follows:~\- Day 1: a single dose of 20 mg rosuvastatin calcium (one Crestor® tablet)"

DRUG

20 mg rosuvastatin calcium period 2

\- Day 12: a single dose of 20 mg rosuvastatin calcium (one Crestor® tablet) immediately after the safinamide administration

Trial Locations (1)

6864

CROSS Research SA, Phase I Unit, Arzo

Sponsors
All Listed Sponsors
collaborator

Zambon SpA

INDUSTRY

lead

Cross Research S.A.

INDUSTRY