drugset / Trial / NCT02261103
Bioavailability of Increasing Pramipexole Doses of Oral Extended Release (ER) Tablets in Healthy Male Volunteers
RandomizedCrossoverDouble-blindTreatment
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
Timeline
- Start
- 2006-04
- Primary completion
- 2006-07
- Completion
- —
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Pramipexole | Unknown | 0.375 mg | Oral |
| Subject | Pramipexole | Unknown | 0.75 mg | Oral |
| Subject | Pramipexole | Unknown | 1.5 mg | Oral |
| Subject | Pramipexole | Unknown | 3 mg | Oral |
| Subject | Pramipexole | Unknown | 4.5 mg | Oral |
Indications
No indication recorded.