A Single and Multiple Dose Study to Assess How the Drug Enters, Moves Through and Exits the Body, Safety and Tolerability of Safinamide in Healthy Adult Chinese Volunteers

PHASE1CompletedINTERVENTIONAL
Enrollment

24

Participants

Timeline

Start Date

June 21, 2021

Primary Completion Date

August 20, 2021

Study Completion Date

August 20, 2021

Conditions
Healthy
Interventions
DRUG

Safinamide 50 mg

Safinamide 50mg film-coated tablets will be administered to subjects in Cohort 1. The subjects will receive the tablets orally in the morning, at 8:00±1hour, under fasting conditions, with 240 mL (total volume) of still mineral water. A mouth-and-hand check will be performed immediately after dosing to ensure treatment compliance.

DRUG

Safinamide 100mg

Safinamide 100mg film-coated tablets will be administered to subjects in Cohort 2. The subjects will receive the tablets orally in the morning, at 8:00±1hour, under fasting conditions, with 240 mL (total volume) of still mineral water. A mouth-and-hand check will be performed immediately after dosing to ensure treatment compliance.

Trial Locations (1)

200025

Ruijin Hospital, Shanghai Jiao Tong University School of Med, Shanghai

All Listed Sponsors
lead

Zambon SpA

INDUSTRY