Bioavailability of Increasing Pramipexole Doses of Oral Extended Release (ER) Tablets in Healthy Male Volunteers
Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
Participant gender:
Summary
The objectives of the studies are:
- To demonstrate similar total exposure between pramipexole ER fasted and pramipexole ER
fed after multiple administration of the highest daily dose of 4.5 mg q.d. and to reveal
any food effect leading to uncontrolled release
- To investigate the relative bioavailability of the ER-formulation of pramipexole in
comparison to the IR-formulation at the highest daily dose of 4.5 mg after multiple
dosing
- To demonstrate dose proportionality between the dose strengths of the pramipexole ER
formulation of 0.375, 0.75, 1.5, 3.0, and 4.5 mg after multiple daily (q.d.) dosing