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CompletedNCT01059903Updated May 22, 2012Results posted

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

A Phase 1 interventional study of Rotigotine transdermal patch in Healthy Volunteers, sponsored by UCB Pharma. Completed at 1 site in Germany. Open to male participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-05-22.

Sponsored by UCB Pharma · Phase 1, Interventional, and Basic science

Phase
Phase 1
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
Male
01

Study 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

02

Conditions studied

  • Healthy Volunteers

Keywords

  • Rotigotine
  • Neupro®
  • Transdermal Patch
03

In context

Lead sponsor

UCB Pharma is the lead sponsor of 238 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
Male
Accepts 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

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
05

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
50 participants (actual)

Study arms

  • Experimental
    Rotigotine PR2.2.1 first

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

    Drug: Rotigotine transdermal patch

  • Experimental
    Rotigotine PR2.1.1 first

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

    Drug: Rotigotine transdermal patch

Interventions

  • DrugRotigotine transdermal patch

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

    Also known as: Neupro®

06

What researchers measure

Primary outcomes

  1. 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

  2. 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

  3. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

07

Results

Posted Mar 3, 2011

Participant flow

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.

Period 1: First Intervention- 24 Hours
Participant flow — Period 1: First Intervention- 24 Hours
MilestoneRotigotine PR2.2.1 FirstRotigotine PR2.1.1 First
Started2525
Completed2424
Not completed11
Withdrew: Adverse event11
Period 2: Washout Period (>= 5 Days)
Participant flow — Period 2: Washout Period (>= 5 Days)
MilestoneRotigotine PR2.2.1 FirstRotigotine PR2.1.1 First
Started2424
Completed2424
Not completed00
Period 3: Second Intervention- 24 Hours
Participant flow — Period 3: Second Intervention- 24 Hours
MilestoneRotigotine PR2.2.1 FirstRotigotine PR2.1.1 First
Started2424
Pharmacokinetic set (pks)1822
Completed2424
Not completed00

Outcome measures

PrimaryAUC(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
Reported as:
Mean · ng/ mL*h
AUC(0-tz) of Unconjugated Rotigotine
ng/ mL*hRotigotine PR2.2.1Rotigotine PR2.1.1
AUC(0-tz) of Unconjugated Rotigotine5.2704 ± 3.14355.4724 ± 2.4755
Statistical analysis
  • Rotigotine PR2.2.1 vs Rotigotine PR2.1.1 · ANOVA · Ratio of geometric ls-means: 0.9028 · 90% CI 0.8411 to 0.9690Bioequivalence is concluded if the 90% CIs for the ratio Treatment A/ Treatment B are fully included in the acceptance range from 0.8- 1.25 for AUC(0-tz), AUC(0-inf) and Cmax.
PrimaryCmax 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
Reported as:
Mean · ng/ mL
Cmax of Unconjugated Rotigotine
ng/ mLRotigotine PR2.2.1Rotigotine PR2.1.1
Cmax of Unconjugated Rotigotine0.26156 ± 0.155940.25774 ± 0.11184
Statistical analysis
  • Rotigotine PR2.2.1 vs Rotigotine PR2.1.1 · ANOVA · Ratio of geometric ls-means: 0.9506 · 90% CI 0.8833 to 1.0231Bioequivalence is concluded if the 90% CIs for the ratio Treatment A/ Treatment B are fully included in the acceptance range from 0.8- 1.25 for AUC(0-tz), AUC(0-inf) and Cmax.
PrimaryAUC(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
Reported as:
Mean · ng/ mL*h
AUC(0- ∞) of Unconjugated Rotigotine
ng/ mL*hRotigotine PR2.2.1Rotigotine PR2.1.1
AUC(0- ∞) of Unconjugated Rotigotine5.36933 ± 3.170135.56925 ± 2.49370
Statistical analysis
  • Rotigotine PR2.2.1 vs Rotigotine PR2.1.1 · ANOVA · Ratio of geometric ls-means: 0.9046 · 90% CI 0.8437 to 0.9699Bioequivalence is concluded if the 90% CIs for the ratio Treatment A/ Treatment B are fully included in the acceptance range from 0.8- 1.25 for AUC(0-tz), AUC(0-inf) and Cmax.
SecondaryAUC(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
Reported as:
Mean · ng/ mL*h/ mg
AUC(0-tz) Norm (Apparent Dose) of Unconjugated Rotigotine
ng/ mL*h/ mgRotigotine PR2.2.1Rotigotine PR2.1.1
AUC(0-tz) Norm (Apparent Dose) of Unconjugated Rotigotine2.56504 ± 0.881712.66067 ± 1.02321
SecondaryAUC(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
Reported as:
Mean · ng*h*kg/ mL
AUC(0-tz) Norm (Body Weight) of Unconjugated Rotigotine
ng*h*kg/ mLRotigotine PR2.2.1Rotigotine PR2.1.1
AUC(0-tz) Norm (Body Weight) of Unconjugated Rotigotine412.942 ± 239.918434.101 ± 206.274
SecondaryAUC(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
Reported as:
Mean · ng/ mL*h/ mg
AUC(0- ∞) Norm (Apparent Dose)
ng/ mL*h/ mgRotigotine PR2.2.1Rotigotine PR2.1.1
AUC(0- ∞) Norm (Apparent Dose)2.62042 ± 0.888912.71397 ± 1.03223
SecondaryAUC(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
Reported as:
Mean · ng*h*kg/ mL
AUC(0- ∞) Norm (Body Weight)
ng*h*kg/ mLRotigotine PR2.2.1Rotigotine PR2.1.1
AUC(0- ∞) Norm (Body Weight)420.811 ± 242.327441.761 ± 207.793
SecondaryCmax, 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
Reported as:
Mean · ng/ mL/ mg
Cmax, Norm (Apparent Dose) of Unconjugated Rotigotine
ng/ mL/ mgRotigotine PR2.2.1Rotigotine PR2.1.1
Cmax, Norm (Apparent Dose) of Unconjugated Rotigotine0.128863 ± 0.0459030.126144 ± 0.046104
SecondaryCmax, 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
Reported as:
Mean · ng/ mL*kg
Cmax, Norm (Body Weight) of Unconjugated Rotigotine
ng/ mL*kgRotigotine PR2.2.1Rotigotine PR2.1.1
Cmax, Norm (Body Weight) of Unconjugated Rotigotine20.4935 ± 11.938020.4489 ± 9.3456
SecondaryTmax 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
Reported as:
Mean · hours (h)
Tmax of Unconjugated Rotigotine
hours (h)Rotigotine PR2.2.1Rotigotine PR2.1.1
Tmax of Unconjugated Rotigotine16.78 ± 5.2315.75 ± 5.24
SecondaryMean 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
Reported as:
Mean · hours (h)
Mean Residence Time (MRT) of Unconjugated Rotigotine
hours (h)Rotigotine PR2.2.1Rotigotine PR2.1.1
Mean Residence Time (MRT) of Unconjugated Rotigotine18.473 ± 1.93618.186 ± 2.056
SecondaryRate 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
Reported as:
Mean · 1/ h
Rate Constant of Elimination (λz) of Unconjugated Rotigotine
1/ hRotigotine PR2.2.1Rotigotine PR2.1.1
Rate Constant of Elimination (λz) of Unconjugated Rotigotine0.162587 ± 0.0336630.165400 ± 0.033405
SecondaryTerminal 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
Reported as:
Mean · hours (h)
Terminal Half-Life (t1/2) of Unconjugated Rotigotine
hours (h)Rotigotine PR2.2.1Rotigotine PR2.1.1
Terminal Half-Life (t1/2) of Unconjugated Rotigotine4.4523 ± 0.97014.3752 ± 0.9677
SecondaryApparent 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
Reported as:
Mean · L/ h
Apparent Total Body Clearance (CL/f) of Unconjugated Rotigotine
L/ hRotigotine PR2.2.1Rotigotine PR2.1.1
Apparent Total Body Clearance (CL/f) of Unconjugated Rotigotine1125.11 ± 621.561041.47 ± 640.57
SecondaryApparent 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
Reported as:
Mean · mg
Apparent Dose
mgRotigotine PR2.2.1Rotigotine PR2.1.1
Apparent Dose1.970 ± 0.6372.036 ± 0.597

Adverse events

Collected over Adverse Events were collected up to 14 days after the last patch removal.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Rotigotine PR2.2.1—0/49 (0%)23/49 (46.9%)
Rotigotine PR2.1.1—0/49 (0%)26/49 (53.1%)
Most frequent other events
Showing 10 of 33
Most frequent other events
EventRotigotine PR2.2.1Rotigotine PR2.1.1
FatigueGeneral disorders6/494/49
Application Site PruritusGeneral disorders4/495/49
HeadacheNervous system disorders2/495/49
DizzinessNervous system disorders5/494/49
NauseaGastrointestinal disorders4/492/49
SomnolenceNervous system disorders4/490/49
HyperhidrosisSkin and subcutaneous tissue disorders4/492/49
Lipase IncreasedInvestigations0/493/49
VomitingGastrointestinal disorders2/491/49
DyspepsiaGastrointestinal disorders2/490/49

Baseline characteristics

Age Continuous
Age Continuous(years)Rotigotine PR2.2.1 FirstRotigotine PR2.1.1 FirstTotal
Mean37.1 ± 12.635.6 ± 9.636.3 ± 11.0
Sex: Female, Male
Sex: Female, Male(Participants)Rotigotine PR2.2.1 FirstRotigotine PR2.1.1 FirstTotal
Female000
Male182240
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Rotigotine PR2.2.1 FirstRotigotine PR2.1.1 FirstTotal
Hispanic or Latino000
Not Hispanic or Latino182240
Unknown or Not Reported000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Rotigotine PR2.2.1 FirstRotigotine PR2.1.1 FirstTotal
American Indian or Alaska Native000
Asian000
Native Hawaiian or Other Pacific Islander000
Black or African American000
White182240
More than one race000
Unknown or Not Reported000
Body Mass Index (BMI)
Body Mass Index (BMI)(kg/m^2)Rotigotine PR2.2.1 FirstRotigotine PR2.1.1 FirstTotal
Mean24.42 ± 2.7124.16 ± 2.7524.28 ± 2.70
Height
Height(meter (m))Rotigotine PR2.2.1 FirstRotigotine PR2.1.1 FirstTotal
Mean1.807 ± 0.0831.807 ± 0.0581.807 ± 0.069
Weight
Weight(kilogramm (kg))Rotigotine PR2.2.1 FirstRotigotine PR2.1.1 FirstTotal
Mean79.94 ± 11.7478.88 ± 9.1479.36 ± 10.26
08

Study locations

1 site
  • Moenchengladbach, NRW, Germany
09

References and documents

Publications

  • Elshoff JP, Timmermann L, Schmid M, Arth C, Komenda M, Brunnert M, Bauer L. Comparison of the bioavailability and adhesiveness of different rotigotine transdermal patch formulations. Curr Med Res Opin. 2013 Dec;29(12):1657-62. doi: 10.1185/03007995.2013.841666. Epub 2013 Sep 23. PubMed 24006953 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 22, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01059903
Lead sponsor
UCB Pharma
Responsible party
Sponsor
First posted
Feb 1, 2010
Start date
Jan 2010
Primary completion
Feb 2010
Completion
Mar 2010
Results posted
Mar 3, 2011
Last update
May 22, 2012

Study contacts

UCB Clinical Trial Call Center
study director · +1 877 822 9493 (UCB)

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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