Multiple Dose Bioequivalence Study of Pramipexole Extended Release in Chinese Healthy Male Volunteers

PHASE1CompletedINTERVENTIONAL
Enrollment

24

Participants

Timeline

Start Date

December 31, 2010

Primary Completion Date

January 31, 2011

Conditions
Healthy
Interventions
DRUG

pramipexole extended release

0.375mg once per day for 5 days (cross-over), 0.75mg once per day for 5 days (up-titration), 1.5mg once per day for 5 days (cross-over)

DRUG

pramipexole extended release

0.375mg once per day for 5 days (cross-over), 0.75mg once per day for 5 days (up-titration), 1.5mg once per day for 5 days (cross-over)

DRUG

pramipexole immediate release

0.125mg three times a day for 5 days (crossover), 0.5mg three times a day for 5 days (cross over)

DRUG

pramipexole immediate release

0.125mg three times a day for 5 days (crossover), 0.5mg three times a day for 5 days (cross over)

Trial Locations (1)

Unknown

248.665.86002 Boehringer Ingelheim Investigational Site, Beijing

Sponsors
All Listed Sponsors
lead

Boehringer Ingelheim

INDUSTRY