Study in Healthy Volunteers to Prove That Two Different Formulations of Rotigotine Patches Deliver Equivalent Drug Amount to the Body

Single-site, Open-label, Randomized, Cross-over Trial to Evaluate the Bioequivalence of Single Dose Rotigotine Transdermal Patch (4.5mg/10cm2) Comparing Two Different Formulations

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01059903

Enrollment

Registered

2010-02-01

Start date

2010-01-31

Completion date

2010-03-31

Last updated

2012-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteers

Keywords

Rotigotine, Neupro®, Transdermal Patch

Brief summary

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

Interventions

DRUGRotigotine transdermal patch

Rotigotine 4.5 mg/10 cm\^2 patch applied for 24 hours

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to 55 Years

Healthy volunteers

Yes

Inclusion criteria

* Healthy White, male volunteers between 18 and 55 years of age (inclusive). * BMI between 19 and 28 kg/m\^2 (inclusive)

Exclusion criteria

* Previous participation in a clinical study with Rotigotine * History or current condition of epilepsy and/or seizures * Known clinically relevant allergy or known/suspected clinically relevant drug hypersensitivity * History of significant skin hypersensitivity to adhesives or other transdermal products or recently unresolved contact dermatitis * History or present condition of an atopic or eczematous dermatitis, psoriasis, and/or an active skin disease * Clinically relevant abnormality in physical examination, ECG, vital signs or safety laboratory examinations * Positive HIV, hepatitis B or C test or positive alcohol or drug test * Relevant hepatic or renal dysfunction * Intake of medication that might interfere with the test drug within 2 weeks prior to dosing

Design outcomes

Primary

Measure	Time frame	Description
AUC(0-tz) of Unconjugated Rotigotine	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	The AUC(0-tz) is the area under the concentration-time curve from zero up to the last analytically quantifiable concentration.
Cmax of Unconjugated Rotigotine	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	The Cmax is the maximum plasma concentration.
AUC(0- ∞) of Unconjugated Rotigotine	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	The AUC(0- ∞) is the area under the plasma concentration-time curve from zero up to infinity

Secondary

Measure	Time frame	Description
AUC(0- ∞) Norm (Body Weight)	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	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).
Cmax, Norm (Apparent Dose) of Unconjugated Rotigotine	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	The Cmax, norm (apparent dose) is the maximum plasma concentration normalized by apparent dose (mg).
Cmax, Norm (Body Weight) of Unconjugated Rotigotine	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	The Cmax, norm (BW) is the maximum plasma concentration normalized by body weight (kg).
Tmax of Unconjugated Rotigotine	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	The tmax is the time to reach maximum plasma concentration after patch application.
AUC(0-tz) Norm (Apparent Dose) of Unconjugated Rotigotine	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	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).
Rate Constant of Elimination (λz) of Unconjugated Rotigotine	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	The λz of unconjugated rotigotine is the rate constant of elimination.
Terminal Half-Life (t1/2) of Unconjugated Rotigotine	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	the t1/2 of unconjugated rotigotine is the terminal half-life, calculated as t1/2=ln2/ λz.
Apparent Total Body Clearance (CL/f) of Unconjugated Rotigotine	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	The CL/f of unconjugated rotigotine is the apparent total body clearance.
Apparent Dose	24 hours	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.
Mean Residence Time (MRT) of Unconjugated Rotigotine	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	The MRT is the mean residence time.
AUC(0-tz) Norm (Body Weight) of Unconjugated Rotigotine	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	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).
AUC(0- ∞) Norm (Apparent Dose)	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	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).

Countries

Germany

Participant flow

Recruitment details

A total of 50 healthy, male subjects have been randomized in order to complete the trial with at least 38 subjects qualified for the Pharmacokinetic Set (PKS). Baseline characteristics refer to the PKS which is the primary analysis set.

Pre-assignment details

Eight subjects that fulfilled predefined criteria for patch adhesiveness were excluded from the statistical analysis on the PKS. The predefined criteria were patch adhesiveness smaller than 75% at any timepoint or an adhesiveness lower than 90% for 12 hours or more.

Participants by arm

Arm	Count
Rotigotine PR2.2.1 First Rotigotine transdermal patch 4.5 mg/10cm\^2, test drug product PR2.2.1 followed by Rotigotine transdermal patch 4.5 mg/10cm\^2, reference drug product PR2.1.1 separated by a washout phase of at least 5 days	18
Rotigotine PR2.1.1 First Rotigotine transdermal patch 4.5 mg/10cm\^2, reference drug product PR2.1.1 followed by Rotigotine transdermal patch 4.5 mg/10cm\^2, test drug product PR2.2.1 separated by a washout phase of at least 5 days	22
Total	40

Withdrawals & dropouts

Period	Reason	FG000	FG001
Period 1: First Intervention- 24 Hours	Adverse Event	1	1

Baseline characteristics

Characteristic	Rotigotine PR2.2.1 First	Rotigotine PR2.1.1 First	Total
Age Continuous	37.1 years STANDARD_DEVIATION 12.6	35.6 years STANDARD_DEVIATION 9.6	36.3 years STANDARD_DEVIATION 11
Body Mass Index (BMI)	24.42 kg/m^2 STANDARD_DEVIATION 2.71	24.16 kg/m^2 STANDARD_DEVIATION 2.75	24.28 kg/m^2 STANDARD_DEVIATION 2.7
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants	0 Participants	0 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	18 Participants	22 Participants	40 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants
Height	1.807 meter (m) STANDARD_DEVIATION 0.083	1.807 meter (m) STANDARD_DEVIATION 0.058	1.807 meter (m) STANDARD_DEVIATION 0.069
Race (NIH/OMB) American Indian or Alaska Native	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Asian	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Black or African American	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) More than one race	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) White	18 Participants	22 Participants	40 Participants
Sex: Female, Male Female	0 Participants	0 Participants	0 Participants
Sex: Female, Male Male	18 Participants	22 Participants	40 Participants
Weight	79.94 kilogramm (kg) STANDARD_DEVIATION 11.74	78.88 kilogramm (kg) STANDARD_DEVIATION 9.14	79.36 kilogramm (kg) STANDARD_DEVIATION 10.26

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	23 / 49	26 / 49
serious Total, serious adverse events	0 / 49	0 / 49

Outcome results

Primary

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

Population: Pharmacokinetic Set (PKS)

Arm	Measure	Value (MEAN)	Dispersion
Rotigotine PR2.2.1	AUC(0- ∞) of Unconjugated Rotigotine	5.36933 ng/ mL*h	Standard Deviation 3.17013
Rotigotine PR2.1.1	AUC(0- ∞) of Unconjugated Rotigotine	5.56925 ng/ mL*h	Standard Deviation 2.4937

Comparison: Bioequivalence testing by using the 90% Confidence Interval (CI).90% CI: [0.8437, 0.9699]ANOVA

Primary

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

Population: Pharmacokinetic Set (PKS)

Arm	Measure	Value (MEAN)	Dispersion
Rotigotine PR2.2.1	AUC(0-tz) of Unconjugated Rotigotine	5.2704 ng/ mL*h	Standard Deviation 3.1435
Rotigotine PR2.1.1	AUC(0-tz) of Unconjugated Rotigotine	5.4724 ng/ mL*h	Standard Deviation 2.4755

Comparison: Bioequivalence testing by using the 90% Confidence Interval (CI).90% CI: [0.8411, 0.969]ANOVA

Primary

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

Population: Pharmacokinetic Set (PKS)

Arm	Measure	Value (MEAN)	Dispersion
Rotigotine PR2.2.1	Cmax of Unconjugated Rotigotine	0.26156 ng/ mL	Standard Deviation 0.15594
Rotigotine PR2.1.1	Cmax of Unconjugated Rotigotine	0.25774 ng/ mL	Standard Deviation 0.11184

Comparison: Bioequivalence testing by using the 90% Confidence Interval (CI).90% CI: [0.8833, 1.0231]ANOVA

Secondary

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

Population: Pharmacokinetic Set (PKS)

Arm	Measure	Value (MEAN)	Dispersion
Rotigotine PR2.2.1	Apparent Dose	1.970 mg	Standard Deviation 0.637
Rotigotine PR2.1.1	Apparent Dose	2.036 mg	Standard Deviation 0.597

Secondary

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

Population: Pharmacokinetic Set (PKS)

Arm	Measure	Value (MEAN)	Dispersion
Rotigotine PR2.2.1	Apparent Total Body Clearance (CL/f) of Unconjugated Rotigotine	1125.11 L/ h	Standard Deviation 621.56
Rotigotine PR2.1.1	Apparent Total Body Clearance (CL/f) of Unconjugated Rotigotine	1041.47 L/ h	Standard Deviation 640.57

Secondary

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

Population: Pharmacokinetic Set (PKS)

Arm	Measure	Value (MEAN)	Dispersion
Rotigotine PR2.2.1	AUC(0- ∞) Norm (Apparent Dose)	2.62042 ng/ mL*h/ mg	Standard Deviation 0.88891
Rotigotine PR2.1.1	AUC(0- ∞) Norm (Apparent Dose)	2.71397 ng/ mL*h/ mg	Standard Deviation 1.03223

Secondary

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

Population: Pharmacokinetic Set (PKS)

Arm	Measure	Value (MEAN)	Dispersion
Rotigotine PR2.2.1	AUC(0- ∞) Norm (Body Weight)	420.811 nghkg/ mL	Standard Deviation 242.327
Rotigotine PR2.1.1	AUC(0- ∞) Norm (Body Weight)	441.761 nghkg/ mL	Standard Deviation 207.793

Secondary

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

Population: Pharmacokinetic Set (PKS)

Arm	Measure	Value (MEAN)	Dispersion
Rotigotine PR2.2.1	AUC(0-tz) Norm (Apparent Dose) of Unconjugated Rotigotine	2.56504 ng/ mL*h/ mg	Standard Deviation 0.88171
Rotigotine PR2.1.1	AUC(0-tz) Norm (Apparent Dose) of Unconjugated Rotigotine	2.66067 ng/ mL*h/ mg	Standard Deviation 1.02321

Secondary

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

Population: Pharmacokinetic Set (PKS)

Arm	Measure	Value (MEAN)	Dispersion
Rotigotine PR2.2.1	AUC(0-tz) Norm (Body Weight) of Unconjugated Rotigotine	412.942 nghkg/ mL	Standard Deviation 239.918
Rotigotine PR2.1.1	AUC(0-tz) Norm (Body Weight) of Unconjugated Rotigotine	434.101 nghkg/ mL	Standard Deviation 206.274

Secondary

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

Population: Pharmacokinetic Set (PKS)

Arm	Measure	Value (MEAN)	Dispersion
Rotigotine PR2.2.1	Cmax, Norm (Apparent Dose) of Unconjugated Rotigotine	0.128863 ng/ mL/ mg	Standard Deviation 0.045903
Rotigotine PR2.1.1	Cmax, Norm (Apparent Dose) of Unconjugated Rotigotine	0.126144 ng/ mL/ mg	Standard Deviation 0.046104

Secondary

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

Population: Pharmacokinetic Set (PKS)

Arm	Measure	Value (MEAN)	Dispersion
Rotigotine PR2.2.1	Cmax, Norm (Body Weight) of Unconjugated Rotigotine	20.4935 ng/ mL*kg	Standard Deviation 11.938
Rotigotine PR2.1.1	Cmax, Norm (Body Weight) of Unconjugated Rotigotine	20.4489 ng/ mL*kg	Standard Deviation 9.3456

Secondary

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

Population: Pharmacokinetic Set (PKS)

Arm	Measure	Value (MEAN)	Dispersion
Rotigotine PR2.2.1	Mean Residence Time (MRT) of Unconjugated Rotigotine	18.473 hours (h)	Standard Deviation 1.936
Rotigotine PR2.1.1	Mean Residence Time (MRT) of Unconjugated Rotigotine	18.186 hours (h)	Standard Deviation 2.056

Secondary

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

Population: Pharmacokinetic Set (PKS)

Arm	Measure	Value (MEAN)	Dispersion
Rotigotine PR2.2.1	Rate Constant of Elimination (λz) of Unconjugated Rotigotine	0.162587 1/ h	Standard Deviation 0.033663
Rotigotine PR2.1.1	Rate Constant of Elimination (λz) of Unconjugated Rotigotine	0.165400 1/ h	Standard Deviation 0.033405

Secondary

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

Population: Pharmacokinetic Set (PKS)

Arm	Measure	Value (MEAN)	Dispersion
Rotigotine PR2.2.1	Terminal Half-Life (t1/2) of Unconjugated Rotigotine	4.4523 hours (h)	Standard Deviation 0.9701
Rotigotine PR2.1.1	Terminal Half-Life (t1/2) of Unconjugated Rotigotine	4.3752 hours (h)	Standard Deviation 0.9677

Secondary

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

Population: Pharmacokinetic Set (PKS)

Arm	Measure	Value (MEAN)	Dispersion
Rotigotine PR2.2.1	Tmax of Unconjugated Rotigotine	16.78 hours (h)	Standard Deviation 5.23
Rotigotine PR2.1.1	Tmax of Unconjugated Rotigotine	15.75 hours (h)	Standard Deviation 5.24

Source: ClinicalTrials.gov · Data processed: Mar 22, 2026

Study in Healthy Volunteers to Prove That Two Different Formulations of Rotigotine Patches Deliver Equivalent Drug Amount to the Body

Conditions

Keywords

Brief summary

Related papers

Interventions

Sponsors

Study design

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Secondary

Countries

Participant flow

Recruitment details

Pre-assignment details

Participants by arm

Withdrawals & dropouts

Baseline characteristics

Adverse events

Outcome results

AUC(0- ∞) of Unconjugated Rotigotine

AUC(0-tz) of Unconjugated Rotigotine

Cmax of Unconjugated Rotigotine

Apparent Dose

Apparent Total Body Clearance (CL/f) of Unconjugated Rotigotine

AUC(0- ∞) Norm (Apparent Dose)

AUC(0- ∞) Norm (Body Weight)

AUC(0-tz) Norm (Apparent Dose) of Unconjugated Rotigotine

AUC(0-tz) Norm (Body Weight) of Unconjugated Rotigotine

Cmax, Norm (Apparent Dose) of Unconjugated Rotigotine

Cmax, Norm (Body Weight) of Unconjugated Rotigotine

Mean Residence Time (MRT) of Unconjugated Rotigotine

Rate Constant of Elimination (λz) of Unconjugated Rotigotine

Terminal Half-Life (t1/2) of Unconjugated Rotigotine

Tmax of Unconjugated Rotigotine