The major aim of this study is to investigate and compare the drug amount delivered to the body after sequential application of two Rotigotine patches of two different formulations
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
50
Rotigotine 4.5 mg/10 cm\^2 patch applied for 24 hours
Unnamed facility
Mönchengladbach, North Rhine-Westphalia, Germany
AUC(0-tz) of Unconjugated Rotigotine
The AUC(0-tz) is the area under the concentration-time curve from zero up to the last analytically quantifiable concentration.
Time frame: 0 h (predose), 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 16 h, 24 h (before patch removal in the morning of Day 2), 25 h, 26 h, 28 h, 30 h, 32 h, 36 h, 40 h, and 48 h
Cmax of Unconjugated Rotigotine
The Cmax is the maximum plasma concentration.
Time frame: 0 h (predose), 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 16 h, 24 h (before patch removal in the morning of Day 2), 25 h, 26 h, 28 h, 30 h, 32 h, 36 h, 40 h, and 48 h
AUC(0- ∞) of Unconjugated Rotigotine
The AUC(0- ∞) is the area under the plasma concentration-time curve from zero up to infinity
Time frame: 0 h (predose), 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 16 h, 24 h (before patch removal in the morning of Day 2), 25 h, 26 h, 28 h, 30 h, 32 h, 36 h, 40 h, and 48 h
AUC(0-tz) Norm (Apparent Dose) of Unconjugated Rotigotine
The AUC(0-tz) norm (apparent dose) is the area under the plasma concentration-time curve from zero up to the last analytically quantifiable concentration normalized by apparent dose (mg).
Time frame: 0 h (predose), 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 16 h, 24 h (before patch removal in the morning of Day 2), 25 h, 26 h, 28 h, 30 h, 32 h, 36 h, 40 h, and 48 h
AUC(0-tz) Norm (Body Weight) of Unconjugated Rotigotine
The AUC(0-tz) norm (BW) is the area under the plasma concentration-time curve from zero up to the last analytically quantifiable concentration normalized by body weight (kg).
Time frame: 0 h (predose), 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 16 h, 24 h (before patch removal in the morning of Day 2), 25 h, 26 h, 28 h, 30 h, 32 h, 36 h, 40 h, and 48 h
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
AUC(0- ∞) Norm (Apparent Dose)
The AUC(0-inf) norm (apparent dose) is the area under the plasma concentration-time curve from zero up to infinity normalized by apparent dose (mg).
Time frame: 0 h (predose), 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 16 h, 24 h (before patch removal in the morning of Day 2), 25 h, 26 h, 28 h, 30 h, 32 h, 36 h, 40 h, and 48 h
AUC(0- ∞) Norm (Body Weight)
The AUC(0-inf) norm (BW) is the area under the plasma concentration-time curve from zero up to infinity normalized by body weight (kg).
Time frame: 0 h (predose), 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 16 h, 24 h (before patch removal in the morning of Day 2), 25 h, 26 h, 28 h, 30 h, 32 h, 36 h, 40 h, and 48 h
Cmax, Norm (Apparent Dose) of Unconjugated Rotigotine
The Cmax, norm (apparent dose) is the maximum plasma concentration normalized by apparent dose (mg).
Time frame: 0 h (predose), 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 16 h, 24 h (before patch removal in the morning of Day 2), 25 h, 26 h, 28 h, 30 h, 32 h, 36 h, 40 h, and 48 h
Cmax, Norm (Body Weight) of Unconjugated Rotigotine
The Cmax, norm (BW) is the maximum plasma concentration normalized by body weight (kg).
Time frame: 0 h (predose), 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 16 h, 24 h (before patch removal in the morning of Day 2), 25 h, 26 h, 28 h, 30 h, 32 h, 36 h, 40 h, and 48 h
Tmax of Unconjugated Rotigotine
The tmax is the time to reach maximum plasma concentration after patch application.
Time frame: 0 h (predose), 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 16 h, 24 h (before patch removal in the morning of Day 2), 25 h, 26 h, 28 h, 30 h, 32 h, 36 h, 40 h, and 48 h
Mean Residence Time (MRT) of Unconjugated Rotigotine
The MRT is the mean residence time.
Time frame: 0 h (predose), 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 16 h, 24 h (before patch removal in the morning of Day 2), 25 h, 26 h, 28 h, 30 h, 32 h, 36 h, 40 h, and 48 h
Rate Constant of Elimination (λz) of Unconjugated Rotigotine
The λz of unconjugated rotigotine is the rate constant of elimination.
Time frame: 0 h (predose), 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 16 h, 24 h (before patch removal in the morning of Day 2), 25 h, 26 h, 28 h, 30 h, 32 h, 36 h, 40 h, and 48 h
Terminal Half-Life (t1/2) of Unconjugated Rotigotine
the t1/2 of unconjugated rotigotine is the terminal half-life, calculated as t1/2=ln2/ λz.
Time frame: 0 h (predose), 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 16 h, 24 h (before patch removal in the morning of Day 2), 25 h, 26 h, 28 h, 30 h, 32 h, 36 h, 40 h, and 48 h
Apparent Total Body Clearance (CL/f) of Unconjugated Rotigotine
The CL/f of unconjugated rotigotine is the apparent total body clearance.
Time frame: 0 h (predose), 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 16 h, 24 h (before patch removal in the morning of Day 2), 25 h, 26 h, 28 h, 30 h, 32 h, 36 h, 40 h, and 48 h
Apparent Dose
Apparent dose of unconjugated rotigotine in mg. The apparent dose was calculated by subtraction of the determined residual content of each rotigotine patch from the nominal content of rotigotine in the patch.
Time frame: 24 hours