drugset / Trial / NCT02264132
Increasing Dose Study of Pramipexole in Two-way Cross-over Comparison of ER Tablet Versus IR Tablet in Japanese Healthy Male Volunteers
RandomizedCrossoverOpen-labelTreatment
Summary
The objectives of this study were to investigate relative BA at steady state and to investigate dose proportionality of pharmacokinetic parameters Relative BA at steady state: * Pramipexole 0.375 mg ER tablet q.d. versus pramipexole 0.125 mg IR tablet t.i.d. * Pramipexole 1.5 mg ER tablet q.d. versus pramipexole 0.5 mg IR tablet t.i.d. Dose proportionality of pharmacokinetic parameters: · Pramipexole ER dosages from 0.375 to 1.5 mg q.d.
Timeline
- Start
- 2006-09
- Primary completion
- 2006-11
- Completion
- —
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Pramipexole | Unknown | 0.125 mg | Oral |
| Subject | Pramipexole | Unknown | 0.375 mg | Oral |
| Subject | Pramipexole | Unknown | 0.5 mg | Oral |
| Subject | Pramipexole | Unknown | 1.5 mg | Oral |
Indications
No indication recorded.