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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
24
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)
Time frame: 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.)
Time frame: up to 24 hours after drug administration
Ae0-24,ss (amount of analyte that is eliminated in urine from 0 to 24 hours at steady state)
Relative BA
Time frame: 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)
Dose proportionality (only for ER)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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.)
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Time frame: up to 24 hours after drug administration
Cmax,ss (maximum measured concentration of the analyte in plasma at steady state)
Time frame: up to day 5
Cmin,ss (minimum measured concentration of the analyte in plasma at steady state)
Time frame: up to day 5
PTF (peak-trough fluctuation)
Time frame: up to day 5
tmax,ss (time from last dosing to the maximum concentration of the analyte in plasma at steady state)
Time frame: up to day 5
Cpre,ss (predose concentration of the analyte in plasma at steady state immediately before administration of the next dose)
Time frame: up to day 5
Cavg (average concentration of the analyte in plasma at steady state)
Time frame: up to day 5
t1/2,ss (terminal half-life of the analyte in plasma at steady state)
Time frame: up to day 5
CL/F,ss (apparent clearance of the analyte in plasma at steady state after
Time frame: up to day 5
CLR,ss (renal clearance of the analyte at steady state determined over the dosing interval τ)
Time frame: up to day 5
Vz/F,ss (apparent volume of distribution during the terminal phase λz at steady state following oral administration)
Time frame: up to day 5
Ae0-24,ss (amount of analyte that is eliminated in urine from 0 to 24 hours at steady state)
Time frame: 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)
Time frame: 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)
Time frame: up to 8 hours after drug administration
Number of subjects with adverse events
Time frame: up to 7 days after last drug administration
Assessment of tolerability by investigator on a 4-point scale
Time frame: Day 5