Conditions: Healthy
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 24
Healthy volunteers: yes

Brief summary:
To establish bioequivalence at steady state of:

1)0.375 mg pramipexole extended release tablet q.d. in fasted status versus 0.125 mg pramipexole Immediate release tablet t.i.d. in fasted status 2)1.5 mg pramipexole extended release tablet q.d. in fasted status versus 0.5 mg pramipexole Immediate release tablet t.i.d. in fasted status

To investigate dose proportionality of pharmacokinetics parameters for:

1)pramipexole extended release dosage of 0.375 to 1.5 mg q.d.

Detailed description:

Arms:
arm 1: 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) arm 2: 0.125mg three times a day for 5 days (crossover), 0.5mg three times a day for 5 days (cross over)

Interventions: intervention 1: pramipexole extended release intervention 2: pramipexole extended release intervention 3: pramipexole immediate release intervention 4: pramipexole immediate release
Intervention descriptions: intervention 1: 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) intervention 2: 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) intervention 3: 0.125mg three times a day for 5 days (crossover), 0.5mg three times a day for 5 days (cross over) intervention 4: 0.125mg three times a day for 5 days (crossover), 0.5mg three times a day for 5 days (cross over)

Protocol document: