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The objectives of the studies are:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pramipexole IR, fasted | Active Comparator | Pramipexole immediate release (IR) tablets |
|
| Pramipexole ER, fasted | Experimental | Pramipexole extended release (ER) tablets |
|
| Pramipexole ER, fed | Experimental | Pramipexole extended release tablets with a high-fat meal 30 min before drug administration |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pramipexole ER tablets | Drug |
| ||
| Pramipexole IR tablets |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ=0-24h (AUC0-24,ss) for ER | up to 23 hours after drug application on day 5 | |
| AUC0-24,ss for IR | up to 23 hours after drug application on day 5 | |
| Maximum measured concentration of the analyte in plasma at steady state (Cmax) | up to 23 hours after drug application on day 5 | |
| Area under the concentration-time curve of the analyte in plasma over the time interval 0 to 4h at steady state (AUC0-4,ss) for ER | up to 4 hours after drug application |
| Measure | Description | Time Frame |
|---|---|---|
| Minimum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ (Cmin,ss) | up to 23 hours after drug application on day 5 | |
| Peak-Trough Fluctuation (PTF) | up to 23 hours after drug application on day 5 |
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Inclusion Criteria:
Exclusion Criteria:
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| Drug |
|
| Placebo matching Pramipexole ER tablets | Drug |
|
| Placebo matching Pramipexole IR tablets | Drug |
|
| Standard high-fat breakfast | Other |
|
| Time from last dosing to the maximum concentration of the analyte in plasma at steady state over a uniform dosing interval τ (tmax,ss) | up to 23 hours after drug application on day 5 |
| Area under the concentration-time curve of the analyte in plasma over the time interval 0 to 8 h at steady state (AUC0-8,ss) | up to 8 hours after drug application |
| Predose concentration of the analyte in plasma at steady state immediately before administration of the next dose (Cpre,ss) | predose on days 1 to 5 |
| Average concentration of the analyte in plasma at steady state (Cavg) | up to 23 hours after drug application on day 5 |
| Terminal half-life of the analyte in plasma at steady state (t1/2,ss) | up to 23 hours after drug application on day 5 |
| Mean residence time of the analyte in the body at steady state after p.o. administration (MRTpo,ss) | up to 23 hours after drug application on day 5 |
| Apparent clearance of the analyte in plasma at steady state after extravascular multiple dose administration (CL/F,ss) | up to 23 hours after drug application on day 5 |
| Renal clearance of the analyte at steady state determined over the dosing interval τ (CLR,ss) | up to 23 hours after drug application on day 5 |
| Apparent volume of distribution during the terminal phase λz at steady state following extravascular administration (Vz/F,ss) | up to 23 hours after drug application on day 5 |
| Amount of analyte that is eliminated in urine at steady state from the time point 0 to time point 24 (Ae0-24,ss) | up to 23 hours after drug application on day 5 |
| Amount of analyte that is eliminated in urine at steady state from the time point 0 to time point 8 (Ae0-8,ss) for IR | up to 8 hours after drug application on day 5 |
| Number of subjects with adverse events | up to 7 days after last drug administration |
| Number of subjects with clinically relevant changes in vital signs | up to 7 days after last drug administration |
| Number of subjects with clinically relevant changes in laboratory parameters | up to 7 days after last drug administration |
| Assessment of global tolerability by investigator on a 4-point scale | day 5 of each visit |