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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:
Dose proportionality of pharmacokinetic parameters:
· Pramipexole ER dosages from 0.375 to 1.5 mg q.d.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pramipexole ER tablet versus Pramipexole IR tablet | Experimental |
| |
| Pramipexole IR tablet versus Pramipexole ER tablet | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pramipexole ER tablet | Drug |
| ||
| Measure | Description | Time Frame |
|---|---|---|
| AUCτ,ss=AUC0-24,ss for ER (area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ=24 hours) | up to day 5 | |
| AUC0-24,ss for IR (area under the concentration-time curve of the analyte in plasma over the time interval 0 to 24 hours at steady state) (This parameter was calculated as 3 times of AUC0-8,ss.) | up to 24 hours after drug administration |
| Measure | Description | Time Frame |
|---|---|---|
| Ae0-24,ss (amount of analyte that is eliminated in urine from 0 to 24 hours at steady state) | Relative BA | up to 24 hours after drug administration |
| AUCτ,ss=AUC0-24,ss for ER (area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ=24 hours) |
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Inclusion Criteria:
Exclusion Criteria:
The following exclusion criteria are of special interest for this study:
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| Pramipexole IR tablet |
| Drug |
|
Dose proportionality (only for ER) |
| up to 24 hours after drug administration |
| Cmax,ss (maximum measured concentration of the analyte in plasma at steady state) | Dose proportionality (only for ER) | up to day 5 |
| Ae0-24,ss (amount of analyte that is eliminated in urine from 0 to 24 hours at steady state) | Dose proportionality (only for ER) | up to 24 hours after drug administration |
| AUCτ,ss=AUC0-24,ss for ER (area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ=24 hours) | up to 24 hours after drug administration |
| AUC0-24,ss for IR (area under the concentration-time curve of the analyte in plasma over the time interval 0 to 24 hours at steady state) (This parameter was calculated as 3 times of AUC0-8,ss.) | up to 24 hours after drug administration |
| Cmax,ss (maximum measured concentration of the analyte in plasma at steady state) | up to day 5 |
| Cmin,ss (minimum measured concentration of the analyte in plasma at steady state) | up to day 5 |
| PTF (peak-trough fluctuation) | up to day 5 |
| tmax,ss (time from last dosing to the maximum concentration of the analyte in plasma at steady state) | up to day 5 |
| Cpre,ss (predose concentration of the analyte in plasma at steady state immediately before administration of the next dose) | up to day 5 |
| Cavg (average concentration of the analyte in plasma at steady state) | up to day 5 |
| t1/2,ss (terminal half-life of the analyte in plasma at steady state) | up to day 5 |
| CL/F,ss (apparent clearance of the analyte in plasma at steady state after | up to day 5 |
| CLR,ss (renal clearance of the analyte at steady state determined over the dosing interval τ) | up to day 5 |
| Vz/F,ss (apparent volume of distribution during the terminal phase λz at steady state following oral administration) | up to day 5 |
| Ae0-24,ss (amount of analyte that is eliminated in urine from 0 to 24 hours at steady state) | up to 24 hours after drug administration |
| Ae0-8,ss for IR (amount of analyte that is eliminated in urine from 0 to 8 hours at steady state) | up to 8 hours after drug administration |
| AUC0-8,ss for IR (area under the concentration-time curve of the analyte in plasma over the time interval 0 to 8 hours at steady state) | up to 8 hours after drug administration |
| Number of subjects with adverse events | up to 7 days after last drug administration |
| Assessment of tolerability by investigator on a 4-point scale | Day 5 |