Study to determine the pharmacokinetics (PK) of pramipexole (PPX) after administration of a single dose orally (p.o.) in pediatric patients with the diagnosis of RLS
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
26
Cmax,ss
Maximum concentration of the Pramipexole (PPX) in plasma at steady state over a uniform dosing interval (Cmax,ss).
Time frame: 0.25h before the drug administration on day1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on day 1.
Cmin,ss
Minimum measured concentration of the analyte in plasma at steady state over a uniform dosing interval (Cmin,ss).
Time frame: 0.25h before the drug administration on day1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on day 1.
Cpre,N
Predose concentration of the analyte in plasma at steady state immediately before administration of the next dose N (Cpre,N).
Time frame: 0.25h before the drug administration on day1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on day 1.
Cavg
Average concentration of the analyte in plasma at steady state (Cavg).
Time frame: 0.25h before the drug administration on day1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on day 1.
Tmax,ss
Time from dosing to maximum concentration at steady state (Tmax,ss).
Time frame: 0.25h before the drug administration on day1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on day 1.
Tmin,ss
Time from dosing to minimum concentration at steady state (Tmin,ss ).
Time frame: 0.25h before the drug administration on day1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on day 1.
AUCτ,ss
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Area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval (AUCτ,ss ).
Time frame: 0.25h before the drug administration on day 1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on Day 1.
λz,ss
Terminal rate constant in plasma at steady state (λz,ss ).
Time frame: 0.25h before the drug administration on day1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on day 1.
t1/2,ss
Terminal half-life of the analyte in plasma at steady state (t1/2,ss ).
Time frame: 0.25h before the drug administration on day1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on day 1.
MRTpo,ss
Mean residence time of the analyte in the body at steady state (MRTpo,ss).
Time frame: 0.25h before the drug administration on day1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on day 1.
CL/F,ss
Apparent clearance of the analyte in the plasma after extravascular administration at steady state; F = absolute bioavailability factor (CL/F,ss ).
Time frame: 0.25h before the drug administration on day1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on day 1.
Vz/F,ss
Apparent volume of distribution during the terminal phase λz following an extravascular dose at steady state (Vz/F,ss ).
Time frame: 0.25h before the drug administration on day1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on day 1.
Ae 0-12,ss
Amount of analyte that is eliminated in urine at steady state over a time interval t1to t2 (0-12h).
Time frame: 12 hours after last study drug administration on day 1
fe 0-12,ss
Fraction of administered drug excreted unchanged in urine at steady state over a time interval t1 to t2 (fe 0-12,ss ).
Time frame: 12 hours after last study drug administration on day 1.
CLR,ss
Renal clearance of the analyte at steady state (CLR(0-12),ss ).
Time frame: 12h after last study drug administration on day 1
PTF
Peak-trough fluctuation (PTF) is defined as the difference between Cmax and Cmin divided by Cavg and multiplied with 100% at steady-state.
Time frame: 0.25h before the drug administration on day1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on day 1.
Number of Patients With Drug Related Adverse Events
Number of patients with adverse events due to study drug.
Time frame: From first drug administration until 24 hours after last study drug administration, upto 48 days
Vital Signs (Systolic and Diastolic Blood Pressure)
Vital signs (Systolic and diastolic blood pressure (both supine and after standing for 1 minute)).
Time frame: -0:15h(hours) pre-dose, and 0:30h, 1:00h, 2:00h, 3:00h, 5:00h, 7:00h, 12:00h, 24:00h post-dose.
Vital Signs (Pulse Rate)
Vital signs (Pulse rate (both supine and after standing for 1 minute)).
Time frame: -0:15h(hours) pre-dose, and 0:30h, 1:00h, 2:00h, 3:00h, 5:00h, 7:00h, 12:00h, 24:00h