Restless Legs Syndrome
Conditions
Brief summary
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
Interventions
DRUGMIRAPEX® - low
DRUGMIRAPEX® - medium
DRUGMIRAPEX® - high
Sponsors
Boehringer Ingelheim
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Years to 16 Years
Healthy volunteers
No
Inclusion criteria
1. Male or female patients ages 6 years to 16 years (two age groups, 6 to 11 years and 12 to 16 years, with the same number of patients if possible) 2. Diagnosis of idiopathic Restless Legs Syndrome (RLS) according to the Clinical RLS criteria of the International Restless Legs Syndrome Study Group (IRLSSG) All 4 of the following criteria must be present: * An urge to move the legs, usually accompanied or caused by uncomfortable and unpleasant sensations in the legs. (Sometimes the urge to move is present without the uncomfortable sensations and sometimes the arms or other body parts are involved in addition to the legs.) * The urge to move or unpleasant sensations begin or worsen during periods of rest or inactivity such as lying or sitting * The urge to move or unpleasant sensations are partially or totally relieved by movement, such as walking or stretching, at least as long as the activity continues * The urge to move or unpleasant sensations are worse in the evening or night than during the day or only occur in the evening or night. (When symptoms are very severe, the worsening at night may not be noticeable but must have been previously present.) 3. Must meet all 4 of the diagnostic criteria for adult RLS (see inclusion criterion No. 2 above) and either: 1. The child must be able to describe the leg discomfort in their own words or 2. The child must have 2 or 3 of the following: * Sleep disturbance * Periodic Limb Movements During Sleep (PLMS) index \>5 per hour of sleep, or * A biological parent or sibling with definite RLS 4. Written informed consent consistent with International Conference on Harmonisation (ICH)/ Good Clinical Practice (GCP) and Local Institutional Review Board requirements for children obtained prior to any study procedures being performed 5. Ability and willingness to comply with the study treatment regimen and to attend study assessments 6. Must be on PPX treatment at the same evening maintenance dose for a minimum of 7 days prior to entry into this study as determined by the investigator 7. A patient who is taking PPX but not as an evening maintenance dose may return for a repeat screening if the patient can be successfully switched and re-stabilized to an evening PPX maintenance dose
Exclusion criteria
1. Any women of childbearing potential having a positive serum pregnancy test at screening 2. Any women of childbearing potential not using a medically accepted method of contraceptive (Intra-Uterine Device, oral, implantable, injectable contraceptives and estrogen patch, double barrier method \[spermicide + diaphragm\], or abstinence at the discretion of the investigator) 3. Patients who have a clinically significant renal disease or serum creatinine level greater than 1.0 mg/dL at screening 4. Any of the following lab results at screening: * Hemoglobin (Hgb) below the lower limit of normal (LLN), which is determined to be clinically significant * Basal thyroid stimulating hormone (TSH), triiodothyronine (T3) or thyroxine (T4) clinically significantly (at the investigator's discretion) out of the normal range at screening (if not caused by substitution therapy according to the investigator's opinion) * Patients with any clinically significant abnormalities in laboratory parameters at screening at the investigator's discretion 5. Other clinically significant metabolic-endocrine, hematological, gastrointestinal disease, pulmonary disease (such as severe asthma) which in the opinion of the investigator would preclude the patient from participating in this study 6. History or clinical signs of any neurological disease with potential to secondarily cause RLS symptoms 7. Presence of any other sleep disorder such as Rapid Eye Movement (REM) sleep behavior disorder, narcolepsy, or sleep apnea syndrome 8. History of schizophrenia or any psychotic disorder, history of mental disorders, or any present Axis I psychiatric disorder according to the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV) requiring any medical therapy 9. History of/or clinical signs of epilepsy or seizures other than fever-related seizures in early childhood 10. History of/or clinical signs of any malignant neoplasm including suspicious undiagnosed skin lesions (which may be melanoma), melanoma, or a history of melanoma 11. Any other conditions that, in the opinion of the investigator, would interfere with the evaluation of the results or constitute a health hazard for the patient 12. Allergic response to PPX or the inactive ingredients in its tablet formulation 13. Had previous treatment with dopamine agonists other than PPX within 14 days prior to the baseline visit 14. Had any other medical treatment for RLS besides the study medication within 14 days prior to the baseline visit 15. Had withdrawal symptoms of any medication at screening or at the baseline visit
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PTF | 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. | Peak-trough fluctuation (PTF) is defined as the difference between Cmax and Cmin divided by Cavg and multiplied with 100% at steady-state. |
| Ae 0-12,ss | 12 hours after last study drug administration on day 1 | Amount of analyte that is eliminated in urine at steady state over a time interval t1to t2 (0-12h). |
| fe 0-12,ss | 12 hours after last study drug administration on day 1. | Fraction of administered drug excreted unchanged in urine at steady state over a time interval t1 to t2 (fe 0-12,ss ). |
| CLR,ss | 12h after last study drug administration on day 1 | Renal clearance of the analyte at steady state (CLR(0-12),ss ). |
| Cmax,ss | 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. | Maximum concentration of the Pramipexole (PPX) in plasma at steady state over a uniform dosing interval (Cmax,ss). |
| Cmin,ss | 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. | Minimum measured concentration of the analyte in plasma at steady state over a uniform dosing interval (Cmin,ss). |
| Cpre,N | 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. | Predose concentration of the analyte in plasma at steady state immediately before administration of the next dose N (Cpre,N). |
| Cavg | 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. | Average concentration of the analyte in plasma at steady state (Cavg). |
| Tmax,ss | 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. | Time from dosing to maximum concentration at steady state (Tmax,ss). |
| Tmin,ss | 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. | Time from dosing to minimum concentration at steady state (Tmin,ss ). |
| AUCτ,ss | 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. | Area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval (AUCτ,ss ). |
| λz,ss | 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. | Terminal rate constant in plasma at steady state (λz,ss ). |
| t1/2,ss | 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. | Terminal half-life of the analyte in plasma at steady state (t1/2,ss ). |
| MRTpo,ss | 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. | Mean residence time of the analyte in the body at steady state (MRTpo,ss). |
| CL/F,ss | 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. | Apparent clearance of the analyte in the plasma after extravascular administration at steady state; F = absolute bioavailability factor (CL/F,ss ). |
| Vz/F,ss | 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. | Apparent volume of distribution during the terminal phase λz following an extravascular dose at steady state (Vz/F,ss ). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Vital Signs (Systolic and Diastolic Blood Pressure) | -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 (Systolic and diastolic blood pressure (both supine and after standing for 1 minute)). |
| Vital Signs (Pulse Rate) | -0:15h(hours) pre-dose, and 0:30h, 1:00h, 2:00h, 3:00h, 5:00h, 7:00h, 12:00h, 24:00h | Vital signs (Pulse rate (both supine and after standing for 1 minute)). |
| Number of Patients With Drug Related Adverse Events | From first drug administration until 24 hours after last study drug administration, upto 48 days | Number of patients with adverse events due to study drug. |
Participant flow
Pre-assignment details
Open label, single dose pharmacokinetic study in pediatric patients with a diagnosis of idiopathic Restless Legs Syndrome(RLS). For the dose MIRAPEX(0.5 mg),Only 2 subjects (12 to\<18 years) were recruited and it was not likely that patients for this dose will be fully recruited so the recruitment was stopped and terminated for this dose only.
Participants by arm
| Arm | Count |
|---|---|
| PPX (MIRAPEX®, 0.125 mg) Orally administered single daily maintenance dose of MIRAPEX® (0.125 mg) tablet per day in evening with 240 mL of water in a fasting state. | 9 |
| PPX (MIRAPEX®, 0.25 mg) Orally administered single daily maintenance dose of MIRAPEX® (0.25 mg) tablet per day in evening with 240 mL of water in a fasting state. | 15 |
| PPX (MIRAPEX®, 0.5 mg) Orally administered single daily maintenance dose of MIRAPEX® (0.5 mg) tablet per day in evening with 240 mL of water in a fasting state. | 2 |
| Total | 26 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 0 | 1 |
| Overall Study | Withdrawal by Subject | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | PPX (MIRAPEX®, 0.125 mg) | PPX (MIRAPEX®, 0.25 mg) | PPX (MIRAPEX®, 0.5 mg) | Total |
|---|---|---|---|---|
| Age, Continuous | 10.6 years STANDARD_DEVIATION 4.3 | 11.4 years STANDARD_DEVIATION 3.4 | 15.0 years STANDARD_DEVIATION 0 | 11.4 years STANDARD_DEVIATION 3.7 |
| Sex: Female, Male Female | 5 Participants | 5 Participants | 2 Participants | 12 Participants |
| Sex: Female, Male Male | 4 Participants | 10 Participants | 0 Participants | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 2 / 9 | 3 / 15 | 1 / 2 |
| serious Total, serious adverse events | 0 / 9 | 0 / 15 | 0 / 2 |
Outcome results
Primary
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
Population: Pharmacokinetic Set (PK): All evaluable patients who received at least one dose of Pramipexole (PPX) between 0.125 and 0.5 mg were included in the PK analysis.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| PPX (MIRAPEX®, 0.125 mg) | Ae 0-12,ss | 6 to <12 years (N=4, 6, 0) | 50600 ng | Geometric Coefficient of Variation 14.6 |
| PPX (MIRAPEX®, 0.125 mg) | Ae 0-12,ss | 12 to <18 years (N=3, 6, 0) | 55200 ng | Geometric Coefficient of Variation 41.5 |
| PPX (MIRAPEX®, 0.25 mg) | Ae 0-12,ss | 6 to <12 years (N=4, 6, 0) | 123000 ng | Geometric Coefficient of Variation 50.7 |
| PPX (MIRAPEX®, 0.25 mg) | Ae 0-12,ss | 12 to <18 years (N=3, 6, 0) | 82300 ng | Geometric Coefficient of Variation 52.7 |
| PPX (MIRAPEX®, 0.5 mg) | Ae 0-12,ss | 6 to <12 years (N=4, 6, 0) | NA ng | — |
| PPX (MIRAPEX®, 0.5 mg) | Ae 0-12,ss | 12 to <18 years (N=3, 6, 0) | NA ng | — |
Primary
AUCτ,ss
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.
Population: Pharmacokinetic Set (PK): All evaluable patients who received at least one dose of Pramipexole (PPX) between 0.125 and 0.5 mg were included in the PK analysis.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| PPX (MIRAPEX®, 0.125 mg) | AUCτ,ss | 6 to <12 years (N=5, 8, 0) | 5.12 ng*h/mL | Geometric Coefficient of Variation 27.4 |
| PPX (MIRAPEX®, 0.125 mg) | AUCτ,ss | 12 to <18 years (N=4, 6, 1) | 3.28 ng*h/mL | Geometric Coefficient of Variation 21.3 |
| PPX (MIRAPEX®, 0.25 mg) | AUCτ,ss | 6 to <12 years (N=5, 8, 0) | 11.0 ng*h/mL | Geometric Coefficient of Variation 42.8 |
| PPX (MIRAPEX®, 0.25 mg) | AUCτ,ss | 12 to <18 years (N=4, 6, 1) | 7.42 ng*h/mL | Geometric Coefficient of Variation 35.2 |
| PPX (MIRAPEX®, 0.5 mg) | AUCτ,ss | 6 to <12 years (N=5, 8, 0) | NA ng*h/mL | — |
| PPX (MIRAPEX®, 0.5 mg) | AUCτ,ss | 12 to <18 years (N=4, 6, 1) | NA ng*h/mL | — |
Primary
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.
Population: Pharmacokinetic Set (PK): All evaluable patients who received at least one dose of Pramipexole (PPX) between 0.125 and 0.5 mg were included in the PK analysis.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| PPX (MIRAPEX®, 0.125 mg) | Cavg | 6 to <12 years (N=5, 8, 0) | 0.213 ng/mL | Geometric Coefficient of Variation 27.4 |
| PPX (MIRAPEX®, 0.125 mg) | Cavg | 12 to <18 years (N=4, 6, 1) | 0.137 ng/mL | Geometric Coefficient of Variation 21.3 |
| PPX (MIRAPEX®, 0.25 mg) | Cavg | 6 to <12 years (N=5, 8, 0) | 0.458 ng/mL | Geometric Coefficient of Variation 42.8 |
| PPX (MIRAPEX®, 0.25 mg) | Cavg | 12 to <18 years (N=4, 6, 1) | 0.309 ng/mL | Geometric Coefficient of Variation 35.2 |
| PPX (MIRAPEX®, 0.5 mg) | Cavg | 6 to <12 years (N=5, 8, 0) | NA ng/mL | — |
| PPX (MIRAPEX®, 0.5 mg) | Cavg | 12 to <18 years (N=4, 6, 1) | NA ng/mL | — |
Primary
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.
Population: Pharmacokinetic Set (PK): All evaluable patients who received at least one dose of Pramipexole (PPX) between 0.125 and 0.5 mg were included in the PK analysis.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| PPX (MIRAPEX®, 0.125 mg) | CL/F,ss | 6 to <12 years (N=5, 8, 0) | 284 mL/min | Geometric Coefficient of Variation 27.4 |
| PPX (MIRAPEX®, 0.125 mg) | CL/F,ss | 12 to <18 years (N=4, 6, 1) | 444 mL/min | Geometric Coefficient of Variation 21.3 |
| PPX (MIRAPEX®, 0.25 mg) | CL/F,ss | 6 to <12 years (N=5, 8, 0) | 265 mL/min | Geometric Coefficient of Variation 42.8 |
| PPX (MIRAPEX®, 0.25 mg) | CL/F,ss | 12 to <18 years (N=4, 6, 1) | 393 mL/min | Geometric Coefficient of Variation 35.2 |
| PPX (MIRAPEX®, 0.5 mg) | CL/F,ss | 6 to <12 years (N=5, 8, 0) | NA mL/min | — |
| PPX (MIRAPEX®, 0.5 mg) | CL/F,ss | 12 to <18 years (N=4, 6, 1) | NA mL/min | — |
Primary
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
Population: Pharmacokinetic Set (PK): All evaluable patients who received at least one dose of Pramipexole (PPX) between 0.125 and 0.5 mg were included in the PK analysis.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| PPX (MIRAPEX®, 0.125 mg) | CLR,ss | 6 to <12 years (N=4, 2, 0) | 201 mL/min | Geometric Coefficient of Variation 34.1 |
| PPX (MIRAPEX®, 0.125 mg) | CLR,ss | 12 to <18 years (N=2, 5, 0) | NA mL/min | — |
| PPX (MIRAPEX®, 0.25 mg) | CLR,ss | 6 to <12 years (N=4, 2, 0) | NA mL/min | — |
| PPX (MIRAPEX®, 0.25 mg) | CLR,ss | 12 to <18 years (N=2, 5, 0) | 253 mL/min | Geometric Coefficient of Variation 34.1 |
| PPX (MIRAPEX®, 0.5 mg) | CLR,ss | 6 to <12 years (N=4, 2, 0) | NA mL/min | — |
| PPX (MIRAPEX®, 0.5 mg) | CLR,ss | 12 to <18 years (N=2, 5, 0) | NA mL/min | — |
Primary
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.
Population: Pharmacokinetic Set (PK): All evaluable patients who received at least one dose of Pramipexole (PPX) between 0.125 and 0.5 mg were included in the PK analysis.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| PPX (MIRAPEX®, 0.125 mg) | Cmax,ss | 6 to <12 years (N=5, 9, 0) | 0.633 ng/mL | Geometric Coefficient of Variation 26.2 |
| PPX (MIRAPEX®, 0.125 mg) | Cmax,ss | 12 to <18 years(N=4, 6, 2)) | 0.396 ng/mL | Geometric Coefficient of Variation 30 |
| PPX (MIRAPEX®, 0.25 mg) | Cmax,ss | 6 to <12 years (N=5, 9, 0) | 1.13 ng/mL | Geometric Coefficient of Variation 35.3 |
| PPX (MIRAPEX®, 0.25 mg) | Cmax,ss | 12 to <18 years(N=4, 6, 2)) | 0.677 ng/mL | Geometric Coefficient of Variation 40.3 |
| PPX (MIRAPEX®, 0.5 mg) | Cmax,ss | 6 to <12 years (N=5, 9, 0) | NA ng/mL | — |
| PPX (MIRAPEX®, 0.5 mg) | Cmax,ss | 12 to <18 years(N=4, 6, 2)) | NA ng/mL | — |
Primary
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.
Population: Pharmacokinetic Set (PK): All evaluable patients who received at least one dose of Pramipexole (PPX) between 0.125 and 0.5 mg were included in the PK analysis.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| PPX (MIRAPEX®, 0.125 mg) | Cmin,ss | 6 to <12 years (N=5, 9, 0) | 0.0872 ng/mL | Standard Deviation 35.5 |
| PPX (MIRAPEX®, 0.125 mg) | Cmin,ss | 12 to <18 years(N=4, 6, 2) | 0.0972 ng/mL | Standard Deviation 37.5 |
| PPX (MIRAPEX®, 0.25 mg) | Cmin,ss | 6 to <12 years (N=5, 9, 0) | 0.136 ng/mL | Standard Deviation 99.5 |
| PPX (MIRAPEX®, 0.25 mg) | Cmin,ss | 12 to <18 years(N=4, 6, 2) | 0.122 ng/mL | Standard Deviation 53.8 |
| PPX (MIRAPEX®, 0.5 mg) | Cmin,ss | 6 to <12 years (N=5, 9, 0) | NA ng/mL | — |
| PPX (MIRAPEX®, 0.5 mg) | Cmin,ss | 12 to <18 years(N=4, 6, 2) | NA ng/mL | — |
Primary
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.
Population: Pharmacokinetic Set (PK): All evaluable patients who received at least one dose of Pramipexole (PPX) between 0.125 and 0.5 mg were included in the PK analysis.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| PPX (MIRAPEX®, 0.125 mg) | Cpre,N | 6 to <12 years (N=4, 8, 0) | 0.074 ng/mL | Geometric Coefficient of Variation 17.3 |
| PPX (MIRAPEX®, 0.125 mg) | Cpre,N | 12 to <18 years (N=1, 5, 1) | NA ng/mL | — |
| PPX (MIRAPEX®, 0.25 mg) | Cpre,N | 6 to <12 years (N=4, 8, 0) | 0.147 ng/mL | Geometric Coefficient of Variation 75.3 |
| PPX (MIRAPEX®, 0.25 mg) | Cpre,N | 12 to <18 years (N=1, 5, 1) | 0.112 ng/mL | Geometric Coefficient of Variation 60.7 |
| PPX (MIRAPEX®, 0.5 mg) | Cpre,N | 6 to <12 years (N=4, 8, 0) | NA ng/mL | — |
| PPX (MIRAPEX®, 0.5 mg) | Cpre,N | 12 to <18 years (N=1, 5, 1) | NA ng/mL | — |
Primary
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.
Population: Pharmacokinetic Set (PK): All evaluable patients who received at least one dose of Pramipexole (PPX) between 0.125 and 0.5 mg were included in the PK analysis.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| PPX (MIRAPEX®, 0.125 mg) | fe 0-12,ss | 6 to <12 years (N=4, 2, 0) | 58.0 % of PPX excreted | Geometric Coefficient of Variation 14.6 |
| PPX (MIRAPEX®, 0.125 mg) | fe 0-12,ss | 12 to <18 years (N=2, 5, 0) | NA % of PPX excreted | — |
| PPX (MIRAPEX®, 0.25 mg) | fe 0-12,ss | 6 to <12 years (N=4, 2, 0) | NA % of PPX excreted | — |
| PPX (MIRAPEX®, 0.25 mg) | fe 0-12,ss | 12 to <18 years (N=2, 5, 0) | 42.0 % of PPX excreted | Geometric Coefficient of Variation 48.1 |
| PPX (MIRAPEX®, 0.5 mg) | fe 0-12,ss | 6 to <12 years (N=4, 2, 0) | NA % of PPX excreted | — |
| PPX (MIRAPEX®, 0.5 mg) | fe 0-12,ss | 12 to <18 years (N=2, 5, 0) | NA % of PPX excreted | — |
Primary
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.
Population: Pharmacokinetic Set (PK): All evaluable patients who received at least one dose of Pramipexole (PPX) between 0.125 and 0.5 mg were included in the PK analysis.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| PPX (MIRAPEX®, 0.125 mg) | MRTpo,ss | 6 to <12 years (N=5, 8, 0) | 8.19 h | Geometric Coefficient of Variation 13.1 |
| PPX (MIRAPEX®, 0.125 mg) | MRTpo,ss | 12 to <18 years (N=4, 6, 1) | 9.47 h | Geometric Coefficient of Variation 5.3 |
| PPX (MIRAPEX®, 0.25 mg) | MRTpo,ss | 6 to <12 years (N=5, 8, 0) | 10.1 h | Geometric Coefficient of Variation 19.5 |
| PPX (MIRAPEX®, 0.25 mg) | MRTpo,ss | 12 to <18 years (N=4, 6, 1) | 11.6 h | Geometric Coefficient of Variation 23.3 |
| PPX (MIRAPEX®, 0.5 mg) | MRTpo,ss | 6 to <12 years (N=5, 8, 0) | NA h | — |
| PPX (MIRAPEX®, 0.5 mg) | MRTpo,ss | 12 to <18 years (N=4, 6, 1) | NA h | — |
Primary
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.
Population: Pharmacokinetic Set (PK): All evaluable patients who received at least one dose of Pramipexole (PPX) between 0.125 and 0.5 mg were included in the PK analysis.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| PPX (MIRAPEX®, 0.125 mg) | PTF | 6 to <12 years (N=5, 8, 0) | 250 % of PTF | Geometric Coefficient of Variation 10.1 |
| PPX (MIRAPEX®, 0.125 mg) | PTF | 12 to <18 years (N=4, 6, 1) | 216 % of PTF | Geometric Coefficient of Variation 24 |
| PPX (MIRAPEX®, 0.25 mg) | PTF | 6 to <12 years (N=5, 8, 0) | 209 % of PTF | Geometric Coefficient of Variation 31.8 |
| PPX (MIRAPEX®, 0.25 mg) | PTF | 12 to <18 years (N=4, 6, 1) | 168 % of PTF | Geometric Coefficient of Variation 34.2 |
| PPX (MIRAPEX®, 0.5 mg) | PTF | 6 to <12 years (N=5, 8, 0) | NA % of PTF | — |
| PPX (MIRAPEX®, 0.5 mg) | PTF | 12 to <18 years (N=4, 6, 1) | NA % of PTF | — |
Primary
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.
Population: Pharmacokinetic Set (PK): All evaluable patients who received at least one dose of Pramipexole (PPX) between 0.125 and 0.5 mg were included in the PK analysis.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| PPX (MIRAPEX®, 0.125 mg) | t1/2,ss | 6 to <12 years (N=5, 8, 0) | 5.26 hours | Geometric Coefficient of Variation 22.6 |
| PPX (MIRAPEX®, 0.125 mg) | t1/2,ss | 12 to <18 years (N=4, 6, 1) | 6.13 hours | Geometric Coefficient of Variation 1.88 |
| PPX (MIRAPEX®, 0.25 mg) | t1/2,ss | 6 to <12 years (N=5, 8, 0) | 6.50 hours | Geometric Coefficient of Variation 20.1 |
| PPX (MIRAPEX®, 0.25 mg) | t1/2,ss | 12 to <18 years (N=4, 6, 1) | 7.39 hours | Geometric Coefficient of Variation 25.4 |
| PPX (MIRAPEX®, 0.5 mg) | t1/2,ss | 6 to <12 years (N=5, 8, 0) | NA hours | — |
| PPX (MIRAPEX®, 0.5 mg) | t1/2,ss | 12 to <18 years (N=4, 6, 1) | NA hours | — |
Primary
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.
Population: Pharmacokinetic Set (PK): All evaluable patients who received at least one dose of Pramipexole (PPX) between 0.125 and 0.5 mg were included in the PK analysis.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| PPX (MIRAPEX®, 0.125 mg) | Tmax,ss | 6 to <12 years (N=5, 9, 0) | 2.00 hours |
| PPX (MIRAPEX®, 0.125 mg) | Tmax,ss | 12 to <18 years (N=4, 6, 2) | 2.00 hours |
| PPX (MIRAPEX®, 0.25 mg) | Tmax,ss | 6 to <12 years (N=5, 9, 0) | 2.00 hours |
| PPX (MIRAPEX®, 0.25 mg) | Tmax,ss | 12 to <18 years (N=4, 6, 2) | 1.96 hours |
| PPX (MIRAPEX®, 0.5 mg) | Tmax,ss | 6 to <12 years (N=5, 9, 0) | NA hours |
| PPX (MIRAPEX®, 0.5 mg) | Tmax,ss | 12 to <18 years (N=4, 6, 2) | NA hours |
Primary
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.
Population: Pharmacokinetic Set (PK): All evaluable subjects who received at least one dose of Pramipexole (PPX) between 0.125 and 0.5 mg were included in the PK analysis.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| PPX (MIRAPEX®, 0.125 mg) | Tmin,ss | 6 to <12 years (N=5, 9, 0) | 12.0 hours |
| PPX (MIRAPEX®, 0.125 mg) | Tmin,ss | 12 to <18 years (N=4, 6, 2) | 6.25 hours |
| PPX (MIRAPEX®, 0.25 mg) | Tmin,ss | 6 to <12 years (N=5, 9, 0) | 24.0 hours |
| PPX (MIRAPEX®, 0.25 mg) | Tmin,ss | 12 to <18 years (N=4, 6, 2) | 23.9 hours |
| PPX (MIRAPEX®, 0.5 mg) | Tmin,ss | 6 to <12 years (N=5, 9, 0) | NA hours |
| PPX (MIRAPEX®, 0.5 mg) | Tmin,ss | 12 to <18 years (N=4, 6, 2) | NA hours |
Primary
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.
Population: Pharmacokinetic Set (PK): All evaluable patients who received at least one dose of Pramipexole (PPX) between 0.125 and 0.5 mg were included in the PK analysis.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| PPX (MIRAPEX®, 0.125 mg) | Vz/F,ss | 6 to <12 years (N=5, 8, 0) | 129 L | Geometric Coefficient of Variation 12.3 |
| PPX (MIRAPEX®, 0.125 mg) | Vz/F,ss | 12 to <18 years (N=4, 6,1) | 236 L | Geometric Coefficient of Variation 19.4 |
| PPX (MIRAPEX®, 0.25 mg) | Vz/F,ss | 6 to <12 years (N=5, 8, 0) | 149 L | Geometric Coefficient of Variation 29.7 |
| PPX (MIRAPEX®, 0.25 mg) | Vz/F,ss | 12 to <18 years (N=4, 6,1) | 251 L | Geometric Coefficient of Variation 37.3 |
| PPX (MIRAPEX®, 0.5 mg) | Vz/F,ss | 6 to <12 years (N=5, 8, 0) | NA L | — |
| PPX (MIRAPEX®, 0.5 mg) | Vz/F,ss | 12 to <18 years (N=4, 6,1) | NA L | — |
Primary
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.
Population: Pharmacokinetic Set (PK): All evaluable patients who received at least one dose of Pramipexole (PPX) between 0.125 and 0.5 mg were included in the PK analysis.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| PPX (MIRAPEX®, 0.125 mg) | λz,ss | 6 to <12 years (N=5, 8, 0) | 0.132 1/h | Geometric Coefficient of Variation 22.6 |
| PPX (MIRAPEX®, 0.125 mg) | λz,ss | 12 to <18 years (N=4, 6, 1) | 0.113 1/h | Geometric Coefficient of Variation 1.88 |
| PPX (MIRAPEX®, 0.25 mg) | λz,ss | 6 to <12 years (N=5, 8, 0) | 0.107 1/h | Geometric Coefficient of Variation 20.1 |
| PPX (MIRAPEX®, 0.25 mg) | λz,ss | 12 to <18 years (N=4, 6, 1) | 0.0938 1/h | Geometric Coefficient of Variation 25.4 |
| PPX (MIRAPEX®, 0.5 mg) | λz,ss | 6 to <12 years (N=5, 8, 0) | NA 1/h | — |
| PPX (MIRAPEX®, 0.5 mg) | λz,ss | 12 to <18 years (N=4, 6, 1) | NA 1/h | — |
Secondary
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
Population: Safety analysis set: The safety population comprised all patients who provided informed consent and received at least one dose of study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PPX (MIRAPEX®, 0.125 mg) | Number of Patients With Drug Related Adverse Events | 1 participants |
| PPX (MIRAPEX®, 0.25 mg) | Number of Patients With Drug Related Adverse Events | 0 participants |
| PPX (MIRAPEX®, 0.5 mg) | Number of Patients With Drug Related Adverse Events | 1 participants |
Secondary
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
Population: Safety analysis set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PPX (MIRAPEX®, 0.125 mg) | Vital Signs (Pulse Rate) | Pulse rate- standing (N=9,15,2): 2:00h | 92.8 bpm | Standard Deviation 17 |
| PPX (MIRAPEX®, 0.125 mg) | Vital Signs (Pulse Rate) | Pulse rate-supine(N=9,15,1): 3:00h | 89.3 bpm | Standard Deviation 19.1 |
| PPX (MIRAPEX®, 0.125 mg) | Vital Signs (Pulse Rate) | Pulse rate- standing (N=9,15,1): 3:00h | 99.0 bpm | Standard Deviation 18.2 |
| PPX (MIRAPEX®, 0.125 mg) | Vital Signs (Pulse Rate) | Pulse rate- standing (N=9,14,1): 5:00h | 99.3 bpm | Standard Deviation 27 |
| PPX (MIRAPEX®, 0.125 mg) | Vital Signs (Pulse Rate) | Pulse rate- standing (N=9,13,1): 7:00h | 100 bpm | Standard Deviation 17 |
| PPX (MIRAPEX®, 0.125 mg) | Vital Signs (Pulse Rate) | Pulse rate-supine(N=9,15,1): 5:00h | 82.7 bpm | Standard Deviation 16 |
| PPX (MIRAPEX®, 0.125 mg) | Vital Signs (Pulse Rate) | Pulse rate- standing (N=9,14,1): 12:00h | 97.8 bpm | Standard Deviation 12.4 |
| PPX (MIRAPEX®, 0.125 mg) | Vital Signs (Pulse Rate) | Pulse rate- standing (N=9,14,1): 24:00h | 90.0 bpm | Standard Deviation 18.8 |
| PPX (MIRAPEX®, 0.125 mg) | Vital Signs (Pulse Rate) | Pulse rate-supine(N=9,14,1): 7:00h | 88.1 bpm | Standard Deviation 18.1 |
| PPX (MIRAPEX®, 0.125 mg) | Vital Signs (Pulse Rate) | Pulse rate-supine(N=9,15,2): 1:00h | 82.7 bpm | Standard Deviation 22.2 |
| PPX (MIRAPEX®, 0.125 mg) | Vital Signs (Pulse Rate) | Pulse rate-supine(N=9,14,1): 12:00h | 77.8 bpm | Standard Deviation 15.2 |
| PPX (MIRAPEX®, 0.125 mg) | Vital Signs (Pulse Rate) | Pulse rate-supine(N=9,14,1): 24:00h | 77.9 bpm | Standard Deviation 13.6 |
| PPX (MIRAPEX®, 0.125 mg) | Vital Signs (Pulse Rate) | Pulse rate-supine(N=9,15,2): -0:15h | 82.4 bpm | Standard Deviation 18.6 |
| PPX (MIRAPEX®, 0.125 mg) | Vital Signs (Pulse Rate) | Pulse rate- standing(N=9,15,2):-0:15h | 90.8 bpm | Standard Deviation 18.3 |
| PPX (MIRAPEX®, 0.125 mg) | Vital Signs (Pulse Rate) | Pulse rate-supine(N=9,15,2): 2:00h | 85.4 bpm | Standard Deviation 19.6 |
| PPX (MIRAPEX®, 0.125 mg) | Vital Signs (Pulse Rate) | Pulse rate- standing(N=9,15,2): 0:30h | 84.7 bpm | Standard Deviation 15.5 |
| PPX (MIRAPEX®, 0.125 mg) | Vital Signs (Pulse Rate) | Pulse rate- standing(N=9,15,2): 1:00h | 94.8 bpm | Standard Deviation 20.3 |
| PPX (MIRAPEX®, 0.125 mg) | Vital Signs (Pulse Rate) | Pulse rate-supine(N=9,15,2): 0:30h | 76.7 bpm | Standard Deviation 17.5 |
| PPX (MIRAPEX®, 0.25 mg) | Vital Signs (Pulse Rate) | Pulse rate-supine(N=9,15,2): -0:15h | 73.3 bpm | Standard Deviation 6.8 |
| PPX (MIRAPEX®, 0.25 mg) | Vital Signs (Pulse Rate) | Pulse rate- standing (N=9,15,2): 2:00h | 89.3 bpm | Standard Deviation 11.2 |
| PPX (MIRAPEX®, 0.25 mg) | Vital Signs (Pulse Rate) | Pulse rate-supine(N=9,14,1): 24:00h | 77.6 bpm | Standard Deviation 8.5 |
| PPX (MIRAPEX®, 0.25 mg) | Vital Signs (Pulse Rate) | Pulse rate-supine(N=9,14,1): 7:00h | 72.0 bpm | Standard Deviation 9 |
| PPX (MIRAPEX®, 0.25 mg) | Vital Signs (Pulse Rate) | Pulse rate- standing (N=9,15,1): 3:00h | 92.7 bpm | Standard Deviation 12.9 |
| PPX (MIRAPEX®, 0.25 mg) | Vital Signs (Pulse Rate) | Pulse rate-supine(N=9,15,1): 3:00h | 79.9 bpm | Standard Deviation 13.6 |
| PPX (MIRAPEX®, 0.25 mg) | Vital Signs (Pulse Rate) | Pulse rate- standing(N=9,15,2): 0:30h | 81.5 bpm | Standard Deviation 12.2 |
| PPX (MIRAPEX®, 0.25 mg) | Vital Signs (Pulse Rate) | Pulse rate- standing (N=9,14,1): 5:00h | 87.1 bpm | Standard Deviation 11.4 |
| PPX (MIRAPEX®, 0.25 mg) | Vital Signs (Pulse Rate) | Pulse rate-supine(N=9,15,2): 0:30h | 78.0 bpm | Standard Deviation 11.7 |
| PPX (MIRAPEX®, 0.25 mg) | Vital Signs (Pulse Rate) | Pulse rate-supine(N=9,15,2): 2:00h | 77.9 bpm | Standard Deviation 8 |
| PPX (MIRAPEX®, 0.25 mg) | Vital Signs (Pulse Rate) | Pulse rate- standing (N=9,13,1): 7:00h | 82.1 bpm | Standard Deviation 14.4 |
| PPX (MIRAPEX®, 0.25 mg) | Vital Signs (Pulse Rate) | Pulse rate-supine(N=9,14,1): 12:00h | 68.6 bpm | Standard Deviation 6.2 |
| PPX (MIRAPEX®, 0.25 mg) | Vital Signs (Pulse Rate) | Pulse rate-supine(N=9,15,2): 1:00h | 75.2 bpm | Standard Deviation 6.8 |
| PPX (MIRAPEX®, 0.25 mg) | Vital Signs (Pulse Rate) | Pulse rate- standing (N=9,14,1): 12:00h | 81.2 bpm | Standard Deviation 12.3 |
| PPX (MIRAPEX®, 0.25 mg) | Vital Signs (Pulse Rate) | Pulse rate-supine(N=9,15,1): 5:00h | 75.9 bpm | Standard Deviation 6.9 |
| PPX (MIRAPEX®, 0.25 mg) | Vital Signs (Pulse Rate) | Pulse rate- standing(N=9,15,2):-0:15h | 79.4 bpm | Standard Deviation 8.7 |
| PPX (MIRAPEX®, 0.25 mg) | Vital Signs (Pulse Rate) | Pulse rate- standing (N=9,14,1): 24:00h | 85.8 bpm | Standard Deviation 6.7 |
| PPX (MIRAPEX®, 0.25 mg) | Vital Signs (Pulse Rate) | Pulse rate- standing(N=9,15,2): 1:00h | 85.4 bpm | Standard Deviation 10.9 |
| PPX (MIRAPEX®, 0.5 mg) | Vital Signs (Pulse Rate) | Pulse rate- standing (N=9,14,1): 24:00h | 86.0 bpm | — |
| PPX (MIRAPEX®, 0.5 mg) | Vital Signs (Pulse Rate) | Pulse rate-supine(N=9,15,2): -0:15h | 75.5 bpm | Standard Deviation 24.7 |
| PPX (MIRAPEX®, 0.5 mg) | Vital Signs (Pulse Rate) | Pulse rate-supine(N=9,15,2): 0:30h | 92.0 bpm | Standard Deviation 32.5 |
| PPX (MIRAPEX®, 0.5 mg) | Vital Signs (Pulse Rate) | Pulse rate-supine(N=9,15,2): 1:00h | 87.0 bpm | Standard Deviation 36.8 |
| PPX (MIRAPEX®, 0.5 mg) | Vital Signs (Pulse Rate) | Pulse rate-supine(N=9,15,2): 2:00h | 94.5 bpm | Standard Deviation 26.2 |
| PPX (MIRAPEX®, 0.5 mg) | Vital Signs (Pulse Rate) | Pulse rate-supine(N=9,15,1): 3:00h | 72.0 bpm | — |
| PPX (MIRAPEX®, 0.5 mg) | Vital Signs (Pulse Rate) | Pulse rate-supine(N=9,15,1): 5:00h | 77.0 bpm | — |
| PPX (MIRAPEX®, 0.5 mg) | Vital Signs (Pulse Rate) | Pulse rate-supine(N=9,14,1): 7:00h | 78.0 bpm | — |
| PPX (MIRAPEX®, 0.5 mg) | Vital Signs (Pulse Rate) | Pulse rate-supine(N=9,14,1): 12:00h | 69.0 bpm | — |
| PPX (MIRAPEX®, 0.5 mg) | Vital Signs (Pulse Rate) | Pulse rate-supine(N=9,14,1): 24:00h | 77.0 bpm | — |
| PPX (MIRAPEX®, 0.5 mg) | Vital Signs (Pulse Rate) | Pulse rate- standing(N=9,15,2):-0:15h | 99.0 bpm | Standard Deviation 22.6 |
| PPX (MIRAPEX®, 0.5 mg) | Vital Signs (Pulse Rate) | Pulse rate- standing(N=9,15,2): 0:30h | 103 bpm | Standard Deviation 27.6 |
| PPX (MIRAPEX®, 0.5 mg) | Vital Signs (Pulse Rate) | Pulse rate- standing(N=9,15,2): 1:00h | 123 bpm | Standard Deviation 43.1 |
| PPX (MIRAPEX®, 0.5 mg) | Vital Signs (Pulse Rate) | Pulse rate- standing (N=9,15,2): 2:00h | 121 bpm | Standard Deviation 1.4 |
| PPX (MIRAPEX®, 0.5 mg) | Vital Signs (Pulse Rate) | Pulse rate- standing (N=9,15,1): 3:00h | 109 bpm | — |
| PPX (MIRAPEX®, 0.5 mg) | Vital Signs (Pulse Rate) | Pulse rate- standing (N=9,14,1): 5:00h | 76.0 bpm | — |
| PPX (MIRAPEX®, 0.5 mg) | Vital Signs (Pulse Rate) | Pulse rate- standing (N=9,13,1): 7:00h | 72.0 bpm | — |
| PPX (MIRAPEX®, 0.5 mg) | Vital Signs (Pulse Rate) | Pulse rate- standing (N=9,14,1): 12:00h | 86.0 bpm | — |
Secondary
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.
Population: Safety analysis set: The safety population comprised all patients who provided informed consent and received at least one dose of study drug.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PPX (MIRAPEX®, 0.125 mg) | Vital Signs (Systolic and Diastolic Blood Pressure) | Diastolic blood pressure-supine(N= 9,15,2): 2:00 | 66.00 mmHg | Standard Deviation 8.23 |
| PPX (MIRAPEX®, 0.125 mg) | Vital Signs (Systolic and Diastolic Blood Pressure) | Diastolic blood pressure-standing(N=9,14,1):12:00h | 74.33 mmHg | Standard Deviation 11.19 |
| PPX (MIRAPEX®, 0.125 mg) | Vital Signs (Systolic and Diastolic Blood Pressure) | Systolic blood pressure-standing(N= 9,13,1): 7:00h | 109.11 mmHg | Standard Deviation 11.76 |
| PPX (MIRAPEX®, 0.125 mg) | Vital Signs (Systolic and Diastolic Blood Pressure) | Diastolic blood pressure-supine(N= 9,15,1): 3:00 | 66.78 mmHg | Standard Deviation 9.36 |
| PPX (MIRAPEX®, 0.125 mg) | Vital Signs (Systolic and Diastolic Blood Pressure) | Systolic blood pressure-supine(N= 9,15,2): -0:15h | 109.33 mmHg | Standard Deviation 6.76 |
| PPX (MIRAPEX®, 0.125 mg) | Vital Signs (Systolic and Diastolic Blood Pressure) | Systolic blood pressure-standing(N= 9,14,1): 5:00h | 110.22 mmHg | Standard Deviation 11.88 |
| PPX (MIRAPEX®, 0.125 mg) | Vital Signs (Systolic and Diastolic Blood Pressure) | Diastolic blood pressure-supine(N= 9,15,1): 5:00 | 64.22 mmHg | Standard Deviation 9.83 |
| PPX (MIRAPEX®, 0.125 mg) | Vital Signs (Systolic and Diastolic Blood Pressure) | Systolic blood pressure-supine(N= 9,15,1): 5:00h | 105.11 mmHg | Standard Deviation 12.71 |
| PPX (MIRAPEX®, 0.125 mg) | Vital Signs (Systolic and Diastolic Blood Pressure) | Systolic blood pressure-standing(N= 9,15,1): 3:00h | 110.11 mmHg | Standard Deviation 16.5 |
| PPX (MIRAPEX®, 0.125 mg) | Vital Signs (Systolic and Diastolic Blood Pressure) | Diastolic blood pressure-supine(N= 9,14,1): 7:00 | 67.56 mmHg | Standard Deviation 13.47 |
| PPX (MIRAPEX®, 0.125 mg) | Vital Signs (Systolic and Diastolic Blood Pressure) | Systolic blood pressure-supine(N= 9,15,2): 1:00h | 113.00 mmHg | Standard Deviation 11.07 |
| PPX (MIRAPEX®, 0.125 mg) | Vital Signs (Systolic and Diastolic Blood Pressure) | Systolic blood pressure-standing(N= 9,15,2): 2:00h | 110.33 mmHg | Standard Deviation 8.76 |
| PPX (MIRAPEX®, 0.125 mg) | Vital Signs (Systolic and Diastolic Blood Pressure) | Diastolic blood pressure-supine(N= 9,14,1): 12:00 | 70.00 mmHg | Standard Deviation 12.03 |
| PPX (MIRAPEX®, 0.125 mg) | Vital Signs (Systolic and Diastolic Blood Pressure) | Diastolic blood pressure-standing(N=9,15,1): 3:00h | 72.67 mmHg | Standard Deviation 5.94 |
| PPX (MIRAPEX®, 0.125 mg) | Vital Signs (Systolic and Diastolic Blood Pressure) | Systolic blood pressure-standing(N= 9,15,2): 1:00h | 110.11 mmHg | Standard Deviation 13.81 |
| PPX (MIRAPEX®, 0.125 mg) | Vital Signs (Systolic and Diastolic Blood Pressure) | Diastolic blood pressure-supine(N= 9,14,1): 24:00 | 66.56 mmHg | Standard Deviation 6 |
| PPX (MIRAPEX®, 0.125 mg) | Vital Signs (Systolic and Diastolic Blood Pressure) | Systolic blood pressure-supine(N= 9,14,1): 7:00h | 108.44 mmHg | Standard Deviation 12.27 |
| PPX (MIRAPEX®, 0.125 mg) | Vital Signs (Systolic and Diastolic Blood Pressure) | Systolic blood pressure-standing(N= 9,15,2): 0:30h | 113.56 mmHg | Standard Deviation 13.62 |
| PPX (MIRAPEX®, 0.125 mg) | Vital Signs (Systolic and Diastolic Blood Pressure) | Systolic blood pressure-standing(N= 9,15,2):-0:15h | 109.89 mmHg | Standard Deviation 8.57 |
| PPX (MIRAPEX®, 0.125 mg) | Vital Signs (Systolic and Diastolic Blood Pressure) | Systolic blood pressure-supine(N= 9,15,2): 0:30h | 112.89 mmHg | Standard Deviation 13.9 |
| PPX (MIRAPEX®, 0.125 mg) | Vital Signs (Systolic and Diastolic Blood Pressure) | Diastolic blood pressure-standing(N=9,15,2): 2:00h | 71.11 mmHg | Standard Deviation 8.82 |
| PPX (MIRAPEX®, 0.125 mg) | Vital Signs (Systolic and Diastolic Blood Pressure) | Systolic blood pressure-supine(N= 9,14,1): 12:00h | 107.56 mmHg | Standard Deviation 16.38 |
| PPX (MIRAPEX®, 0.125 mg) | Vital Signs (Systolic and Diastolic Blood Pressure) | Diastolic blood pressure-standing(N=9,13,1):7:00h | 72.00 mmHg | Standard Deviation 13.01 |
| PPX (MIRAPEX®, 0.125 mg) | Vital Signs (Systolic and Diastolic Blood Pressure) | Diastolic blood pressure-standing(N=9,15,2): 1:00h | 69.22 mmHg | Standard Deviation 6.36 |
| PPX (MIRAPEX®, 0.125 mg) | Vital Signs (Systolic and Diastolic Blood Pressure) | Systolic blood pressure-supine(N= 9,14,1): 24:00h | 109.22 mmHg | Standard Deviation 11.38 |
| PPX (MIRAPEX®, 0.125 mg) | Vital Signs (Systolic and Diastolic Blood Pressure) | Systolic blood pressure-supine(N= 9,15,2): 2:00h | 111.00 mmHg | Standard Deviation 7.43 |
| PPX (MIRAPEX®, 0.125 mg) | Vital Signs (Systolic and Diastolic Blood Pressure) | Diastolic blood pressure-standing(N=9,15,2): 0:30h | 70.11 mmHg | Standard Deviation 7.44 |
| PPX (MIRAPEX®, 0.125 mg) | Vital Signs (Systolic and Diastolic Blood Pressure) | Diastolic blood pressure-supine(N= 9,15,2): -0:15 | 66.67 mmHg | Standard Deviation 7.35 |
| PPX (MIRAPEX®, 0.125 mg) | Vital Signs (Systolic and Diastolic Blood Pressure) | Diastolicblood pressure-standing(N=9,14,1):24:00h | 73.11 mmHg | Standard Deviation 8.13 |
| PPX (MIRAPEX®, 0.125 mg) | Vital Signs (Systolic and Diastolic Blood Pressure) | Diastolicblood pressure-standing(N=9,15,2): -0:15h | 68.11 mmHg | Standard Deviation 11.87 |
| PPX (MIRAPEX®, 0.125 mg) | Vital Signs (Systolic and Diastolic Blood Pressure) | Diastolic blood pressure-supine(N= 9,15,2): 0:30 | 68.67 mmHg | Standard Deviation 8.93 |
| PPX (MIRAPEX®, 0.125 mg) | Vital Signs (Systolic and Diastolic Blood Pressure) | Diastolic blood pressure-standing(N=9,14,1): 5:00h | 74.00 mmHg | Standard Deviation 10.82 |
| PPX (MIRAPEX®, 0.125 mg) | Vital Signs (Systolic and Diastolic Blood Pressure) | Systolic blood pressure-standing(N=9,14,1): 24:00h | 113.89 mmHg | Standard Deviation 11.25 |
| PPX (MIRAPEX®, 0.125 mg) | Vital Signs (Systolic and Diastolic Blood Pressure) | Diastolic blood pressure-supine(N= 9,15,2): 1:00 | 69.33 mmHg | Standard Deviation 6.52 |
| PPX (MIRAPEX®, 0.125 mg) | Vital Signs (Systolic and Diastolic Blood Pressure) | Systolic blood pressure-supine(N= 9,15,1): 3:00h | 106.89 mmHg | Standard Deviation 10.4 |
| PPX (MIRAPEX®, 0.125 mg) | Vital Signs (Systolic and Diastolic Blood Pressure) | Systolic blood pressure-standing(N=9,14,1): 12:00h | 108.22 mmHg | Standard Deviation 9.59 |
| PPX (MIRAPEX®, 0.25 mg) | Vital Signs (Systolic and Diastolic Blood Pressure) | Diastolic blood pressure-standing(N=9,15,1): 3:00h | 71.47 mmHg | Standard Deviation 8.98 |
| PPX (MIRAPEX®, 0.25 mg) | Vital Signs (Systolic and Diastolic Blood Pressure) | Systolic blood pressure-supine(N= 9,15,2): -0:15h | 109.20 mmHg | Standard Deviation 10.8 |
| PPX (MIRAPEX®, 0.25 mg) | Vital Signs (Systolic and Diastolic Blood Pressure) | Systolic blood pressure-supine(N= 9,15,2): 0:30h | 110.33 mmHg | Standard Deviation 14.07 |
| PPX (MIRAPEX®, 0.25 mg) | Vital Signs (Systolic and Diastolic Blood Pressure) | Systolic blood pressure-supine(N= 9,15,2): 1:00h | 108.07 mmHg | Standard Deviation 12.92 |
| PPX (MIRAPEX®, 0.25 mg) | Vital Signs (Systolic and Diastolic Blood Pressure) | Systolic blood pressure-supine(N= 9,15,2): 2:00h | 111.93 mmHg | Standard Deviation 13.79 |
| PPX (MIRAPEX®, 0.25 mg) | Vital Signs (Systolic and Diastolic Blood Pressure) | Systolic blood pressure-supine(N= 9,15,1): 3:00h | 110.53 mmHg | Standard Deviation 11.34 |
| PPX (MIRAPEX®, 0.25 mg) | Vital Signs (Systolic and Diastolic Blood Pressure) | Systolic blood pressure-supine(N= 9,15,1): 5:00h | 108.80 mmHg | Standard Deviation 14.89 |
| PPX (MIRAPEX®, 0.25 mg) | Vital Signs (Systolic and Diastolic Blood Pressure) | Systolic blood pressure-supine(N= 9,14,1): 7:00h | 109.86 mmHg | Standard Deviation 14.11 |
| PPX (MIRAPEX®, 0.25 mg) | Vital Signs (Systolic and Diastolic Blood Pressure) | Systolic blood pressure-supine(N= 9,14,1): 12:00h | 106.93 mmHg | Standard Deviation 16.28 |
| PPX (MIRAPEX®, 0.25 mg) | Vital Signs (Systolic and Diastolic Blood Pressure) | Systolic blood pressure-supine(N= 9,14,1): 24:00h | 112.21 mmHg | Standard Deviation 13.76 |
| PPX (MIRAPEX®, 0.25 mg) | Vital Signs (Systolic and Diastolic Blood Pressure) | Diastolic blood pressure-supine(N= 9,15,2): -0:15 | 65.73 mmHg | Standard Deviation 10.19 |
| PPX (MIRAPEX®, 0.25 mg) | Vital Signs (Systolic and Diastolic Blood Pressure) | Diastolic blood pressure-supine(N= 9,15,2): 0:30 | 65.80 mmHg | Standard Deviation 12.62 |
| PPX (MIRAPEX®, 0.25 mg) | Vital Signs (Systolic and Diastolic Blood Pressure) | Diastolic blood pressure-supine(N= 9,15,2): 1:00 | 65.73 mmHg | Standard Deviation 7.8 |
| PPX (MIRAPEX®, 0.25 mg) | Vital Signs (Systolic and Diastolic Blood Pressure) | Diastolic blood pressure-supine(N= 9,15,2): 2:00 | 65.80 mmHg | Standard Deviation 8.76 |
| PPX (MIRAPEX®, 0.25 mg) | Vital Signs (Systolic and Diastolic Blood Pressure) | Diastolic blood pressure-supine(N= 9,15,1): 3:00 | 65.40 mmHg | Standard Deviation 9.96 |
| PPX (MIRAPEX®, 0.25 mg) | Vital Signs (Systolic and Diastolic Blood Pressure) | Diastolic blood pressure-supine(N= 9,15,1): 5:00 | 63.87 mmHg | Standard Deviation 9.78 |
| PPX (MIRAPEX®, 0.25 mg) | Vital Signs (Systolic and Diastolic Blood Pressure) | Diastolic blood pressure-supine(N= 9,14,1): 7:00 | 62.43 mmHg | Standard Deviation 8.08 |
| PPX (MIRAPEX®, 0.25 mg) | Vital Signs (Systolic and Diastolic Blood Pressure) | Diastolic blood pressure-supine(N= 9,14,1): 12:00 | 61.00 mmHg | Standard Deviation 9.12 |
| PPX (MIRAPEX®, 0.25 mg) | Vital Signs (Systolic and Diastolic Blood Pressure) | Diastolic blood pressure-supine(N= 9,14,1): 24:00 | 65.71 mmHg | Standard Deviation 7.61 |
| PPX (MIRAPEX®, 0.25 mg) | Vital Signs (Systolic and Diastolic Blood Pressure) | Systolic blood pressure-standing(N= 9,15,2):-0:15h | 113.93 mmHg | Standard Deviation 9.97 |
| PPX (MIRAPEX®, 0.25 mg) | Vital Signs (Systolic and Diastolic Blood Pressure) | Systolic blood pressure-standing(N= 9,15,2): 0:30h | 113.67 mmHg | Standard Deviation 13.69 |
| PPX (MIRAPEX®, 0.25 mg) | Vital Signs (Systolic and Diastolic Blood Pressure) | Systolic blood pressure-standing(N= 9,15,2): 1:00h | 110.07 mmHg | Standard Deviation 14.26 |
| PPX (MIRAPEX®, 0.25 mg) | Vital Signs (Systolic and Diastolic Blood Pressure) | Systolic blood pressure-standing(N= 9,15,2): 2:00h | 112.27 mmHg | Standard Deviation 12.26 |
| PPX (MIRAPEX®, 0.25 mg) | Vital Signs (Systolic and Diastolic Blood Pressure) | Systolic blood pressure-standing(N= 9,15,1): 3:00h | 113.07 mmHg | Standard Deviation 16.15 |
| PPX (MIRAPEX®, 0.25 mg) | Vital Signs (Systolic and Diastolic Blood Pressure) | Systolic blood pressure-standing(N= 9,14,1): 5:00h | 111.93 mmHg | Standard Deviation 14.91 |
| PPX (MIRAPEX®, 0.25 mg) | Vital Signs (Systolic and Diastolic Blood Pressure) | Systolic blood pressure-standing(N= 9,13,1): 7:00h | 103.85 mmHg | Standard Deviation 17.56 |
| PPX (MIRAPEX®, 0.25 mg) | Vital Signs (Systolic and Diastolic Blood Pressure) | Systolic blood pressure-standing(N=9,14,1): 12:00h | 107.14 mmHg | Standard Deviation 15.83 |
| PPX (MIRAPEX®, 0.25 mg) | Vital Signs (Systolic and Diastolic Blood Pressure) | Systolic blood pressure-standing(N=9,14,1): 24:00h | 115.50 mmHg | Standard Deviation 14.43 |
| PPX (MIRAPEX®, 0.25 mg) | Vital Signs (Systolic and Diastolic Blood Pressure) | Diastolicblood pressure-standing(N=9,15,2): -0:15h | 71.20 mmHg | Standard Deviation 8.09 |
| PPX (MIRAPEX®, 0.25 mg) | Vital Signs (Systolic and Diastolic Blood Pressure) | Diastolic blood pressure-standing(N=9,15,2): 0:30h | 69.20 mmHg | Standard Deviation 12.11 |
| PPX (MIRAPEX®, 0.25 mg) | Vital Signs (Systolic and Diastolic Blood Pressure) | Diastolic blood pressure-standing(N=9,15,2): 1:00h | 72.00 mmHg | Standard Deviation 9.54 |
| PPX (MIRAPEX®, 0.25 mg) | Vital Signs (Systolic and Diastolic Blood Pressure) | Diastolic blood pressure-standing(N=9,15,2): 2:00h | 73.13 mmHg | Standard Deviation 9.36 |
| PPX (MIRAPEX®, 0.25 mg) | Vital Signs (Systolic and Diastolic Blood Pressure) | Diastolic blood pressure-standing(N=9,14,1): 5:00h | 70.57 mmHg | Standard Deviation 9.2 |
| PPX (MIRAPEX®, 0.25 mg) | Vital Signs (Systolic and Diastolic Blood Pressure) | Diastolic blood pressure-standing(N=9,13,1):7:00h | 66.69 mmHg | Standard Deviation 10.9 |
| PPX (MIRAPEX®, 0.25 mg) | Vital Signs (Systolic and Diastolic Blood Pressure) | Diastolic blood pressure-standing(N=9,14,1):12:00h | 70.07 mmHg | Standard Deviation 10.51 |
| PPX (MIRAPEX®, 0.25 mg) | Vital Signs (Systolic and Diastolic Blood Pressure) | Diastolicblood pressure-standing(N=9,14,1):24:00h | 73.57 mmHg | Standard Deviation 9.62 |
| PPX (MIRAPEX®, 0.5 mg) | Vital Signs (Systolic and Diastolic Blood Pressure) | Diastolic blood pressure-supine(N= 9,15,2): 2:00 | 75.00 mmHg | Standard Deviation 8.49 |
| PPX (MIRAPEX®, 0.5 mg) | Vital Signs (Systolic and Diastolic Blood Pressure) | Diastolic blood pressure-standing(N=9,14,1):12:00h | 62.00 mmHg | — |
| PPX (MIRAPEX®, 0.5 mg) | Vital Signs (Systolic and Diastolic Blood Pressure) | Systolic blood pressure-standing(N= 9,13,1): 7:00h | 65.00 mmHg | — |
| PPX (MIRAPEX®, 0.5 mg) | Vital Signs (Systolic and Diastolic Blood Pressure) | Diastolic blood pressure-supine(N= 9,15,2): 1:00 | 64.00 mmHg | Standard Deviation 12.73 |
| PPX (MIRAPEX®, 0.5 mg) | Vital Signs (Systolic and Diastolic Blood Pressure) | Diastolic blood pressure-standing(N=9,14,1): 5:00h | 98.00 mmHg | — |
| PPX (MIRAPEX®, 0.5 mg) | Vital Signs (Systolic and Diastolic Blood Pressure) | Systolic blood pressure-standing(N=9,14,1): 12:00h | 100.00 mmHg | — |
| PPX (MIRAPEX®, 0.5 mg) | Vital Signs (Systolic and Diastolic Blood Pressure) | Diastolic blood pressure-supine(N= 9,15,2): 0:30 | 73.00 mmHg | Standard Deviation 2.83 |
| PPX (MIRAPEX®, 0.5 mg) | Vital Signs (Systolic and Diastolic Blood Pressure) | Systolic blood pressure-supine(N= 9,15,2): 1:00h | 105.50 mmHg | Standard Deviation 0.71 |
| PPX (MIRAPEX®, 0.5 mg) | Vital Signs (Systolic and Diastolic Blood Pressure) | Systolic blood pressure-standing(N=9,14,1): 24:00h | 102.00 mmHg | — |
| PPX (MIRAPEX®, 0.5 mg) | Vital Signs (Systolic and Diastolic Blood Pressure) | Diastolic blood pressure-supine(N= 9,15,2): -0:15 | 76.00 mmHg | Standard Deviation 0 |
| PPX (MIRAPEX®, 0.5 mg) | Vital Signs (Systolic and Diastolic Blood Pressure) | Systolic blood pressure-supine(N= 9,15,2): -0:15h | 117.00 mmHg | Standard Deviation 4.24 |
| PPX (MIRAPEX®, 0.5 mg) | Vital Signs (Systolic and Diastolic Blood Pressure) | Diastolicblood pressure-standing(N=9,15,2): -0:15h | 86.00 mmHg | Standard Deviation 0 |
| PPX (MIRAPEX®, 0.5 mg) | Vital Signs (Systolic and Diastolic Blood Pressure) | Systolic blood pressure-supine(N= 9,14,1): 24:00h | 120.00 mmHg | — |
| PPX (MIRAPEX®, 0.5 mg) | Vital Signs (Systolic and Diastolic Blood Pressure) | Diastolic blood pressure-standing(N=9,13,1):7:00h | 48.00 mmHg | — |
| PPX (MIRAPEX®, 0.5 mg) | Vital Signs (Systolic and Diastolic Blood Pressure) | Diastolic blood pressure-standing(N=9,15,2): 0:30h | 80.00 mmHg | Standard Deviation 1.41 |
| PPX (MIRAPEX®, 0.5 mg) | Vital Signs (Systolic and Diastolic Blood Pressure) | Systolic blood pressure-supine(N= 9,14,1): 12:00h | 109.00 mmHg | — |
| PPX (MIRAPEX®, 0.5 mg) | Vital Signs (Systolic and Diastolic Blood Pressure) | Systolic blood pressure-supine(N= 9,15,2): 0:30h | 116.00 mmHg | Standard Deviation 4.24 |
| PPX (MIRAPEX®, 0.5 mg) | Vital Signs (Systolic and Diastolic Blood Pressure) | Diastolic blood pressure-standing(N=9,15,2): 1:00h | 91.00 mmHg | Standard Deviation 7.07 |
| PPX (MIRAPEX®, 0.5 mg) | Vital Signs (Systolic and Diastolic Blood Pressure) | Systolic blood pressure-supine(N= 9,14,1): 7:00h | 108.00 mmHg | — |
| PPX (MIRAPEX®, 0.5 mg) | Vital Signs (Systolic and Diastolic Blood Pressure) | Diastolicblood pressure-standing(N=9,14,1):24:00h | 84.00 mmHg | — |
| PPX (MIRAPEX®, 0.5 mg) | Vital Signs (Systolic and Diastolic Blood Pressure) | Systolic blood pressure-standing(N= 9,15,2):-0:15h | 122.00 mmHg | Standard Deviation 9.9 |
| PPX (MIRAPEX®, 0.5 mg) | Vital Signs (Systolic and Diastolic Blood Pressure) | Diastolic blood pressure-supine(N= 9,14,1): 24:00 | 78.00 mmHg | — |
| PPX (MIRAPEX®, 0.5 mg) | Vital Signs (Systolic and Diastolic Blood Pressure) | Diastolic blood pressure-standing(N=9,15,2): 2:00h | 86.50 mmHg | Standard Deviation 3.54 |
| PPX (MIRAPEX®, 0.5 mg) | Vital Signs (Systolic and Diastolic Blood Pressure) | Systolic blood pressure-standing(N= 9,15,2): 0:30h | 115.50 mmHg | Standard Deviation 6.36 |
| PPX (MIRAPEX®, 0.5 mg) | Vital Signs (Systolic and Diastolic Blood Pressure) | Diastolic blood pressure-supine(N= 9,14,1): 12:00 | 66.00 mmHg | — |
| PPX (MIRAPEX®, 0.5 mg) | Vital Signs (Systolic and Diastolic Blood Pressure) | Systolic blood pressure-supine(N= 9,15,1): 5:00h | 104.00 mmHg | — |
| PPX (MIRAPEX®, 0.5 mg) | Vital Signs (Systolic and Diastolic Blood Pressure) | Systolic blood pressure-standing(N= 9,15,2): 1:00h | 125.50 mmHg | Standard Deviation 23.33 |
| PPX (MIRAPEX®, 0.5 mg) | Vital Signs (Systolic and Diastolic Blood Pressure) | Diastolic blood pressure-supine(N= 9,14,1): 7:00 | 67.00 mmHg | — |
| PPX (MIRAPEX®, 0.5 mg) | Vital Signs (Systolic and Diastolic Blood Pressure) | Systolic blood pressure-supine(N= 9,15,1): 3:00h | 113.00 mmHg | — |
| PPX (MIRAPEX®, 0.5 mg) | Vital Signs (Systolic and Diastolic Blood Pressure) | Systolic blood pressure-standing(N= 9,15,2): 2:00h | 115.00 mmHg | Standard Deviation 2.83 |
| PPX (MIRAPEX®, 0.5 mg) | Vital Signs (Systolic and Diastolic Blood Pressure) | Diastolic blood pressure-supine(N= 9,15,1): 5:00 | 70.00 mmHg | — |
| PPX (MIRAPEX®, 0.5 mg) | Vital Signs (Systolic and Diastolic Blood Pressure) | Diastolic blood pressure-standing(N=9,15,1): 3:00h | 79.00 mmHg | — |
| PPX (MIRAPEX®, 0.5 mg) | Vital Signs (Systolic and Diastolic Blood Pressure) | Systolic blood pressure-standing(N= 9,15,1): 3:00h | 108.00 mmHg | — |
| PPX (MIRAPEX®, 0.5 mg) | Vital Signs (Systolic and Diastolic Blood Pressure) | Diastolic blood pressure-supine(N= 9,15,1): 3:00 | 75.00 mmHg | — |
| PPX (MIRAPEX®, 0.5 mg) | Vital Signs (Systolic and Diastolic Blood Pressure) | Systolic blood pressure-supine(N= 9,15,2): 2:00h | 113.00 mmHg | Standard Deviation 9.9 |
| PPX (MIRAPEX®, 0.5 mg) | Vital Signs (Systolic and Diastolic Blood Pressure) | Systolic blood pressure-standing(N= 9,14,1): 5:00h | 115.00 mmHg | — |