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CompletedNCT00881894Updated Oct 27, 2014Results posted

Study in Healthy Volunteers to Prove That 2 Rotigotine Patches From Different Manufacturing Processes Deliver Equivalent Drug Amount to the Body.

A Phase 1 interventional study of Rotigotine transdermal patch in Healthy, 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 2014-10-27.

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

Phase
Phase 1
Study type
Interventional
Enrollment
52
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 2 rotigotine transdermal patches from 2 different manufacturing processes.

02

Conditions studied

  • Healthy

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/m² (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.
  • Thickly hair-covered abdomen resulting in difficulties in finding appropriate patch application sites
05

Study design

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

Study arms

  • Experimental
    Sequence A-B (Test: PR2.1.1 - Reference: PR1.0)

    Two single applications of rotigotine patches from two different manufacturing processes in the order A-B separated by a washout phase of at least 5 days

    Drug: Rotigotine transdermal patch

  • Experimental
    Sequence B-A (Reference: PR1.0 - Test: PR2.1.1)

    Two single applications of rotigotine patches from two different manufacturing processes in the order B-A separated by a washout phase of at least 5 days

    Drug: Rotigotine transdermal patch

Interventions

  • DrugRotigotine transdermal patch

    Rotigotine 4.5mg/10cm\^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 plasma concentration- time curve from zero up to the last analytically quantifiable concentration.

    Time frame: Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application

  2. Cmax of Unconjugated Rotigotine

    The Cmax is the maximum plasma concentration.

    Time frame: Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application.

Secondary outcomes

  1. AUC(0-∞) of Unconjugated Rotigotine

    The AUC(0-∞) is the area under the plasma concentration- time curve from zero up to infinity.

    Time frame: Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application.

  2. 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: Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application.

  3. AUC(0-tz)Norm (BW) 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: Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application.

  4. Cmax,Norm (Apparent Dose) of Unconjugated Rotigotine

    The Cmax,Norm (Apparent dose) is the maximum plasma concentration normalized by apparent dose.

    Time frame: Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application.

  5. Cmax,Norm (BW) of Unconjugated Rotigotine

    The Cmax,Norm (BW) is the maximum plasma concentration normalized by body weight (kg).

    Time frame: Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application.

  6. Tmax of Unconjugated Rotigotine

    The Tmax is the time to reach a maximum plasma concentration after patch application.

    Time frame: Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application.

  7. MRT of Unconjugated Rotigotine

    The MRT is the mean residence time.

    Time frame: Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24(before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application.

  8. λz of Unconjugated Rotigotine

    The λz is the rate constant of elimination.

    Time frame: Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application.

  9. t1/2 of Unconjugated Rotigotine

    The t1/2 is the terminal half- life.

    Time frame: Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application.

  10. CL/f of Unconjugated Rotigotine

    The CL/f is the apparent total body clearance.

    Time frame: Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application.

  11. Apparent Dose

    Apparent dose of unconjugated rotigotine in mg. The Apparent dose of unconjugated rotigotine was determined from the patches removed on Day 2.

    Time frame: 48 hours

07

Results

Posted Dec 25, 2009

Participant flow

A total of 52, healthy, male subjects has been randomized in order to complete the trial with at least 44 subjects eligible for the Pharmacokinetic Set (PKS). Baseline characteristics refer to the PKS.

Participant flow — Overall Study
MilestoneSequence A-B (Test: PR2.1.1 - Reference: PR1.0)Sequence B-A (Reference: PR1.0 - Test: PR2.1.1)
Started2626
Pharmacokinetic set (pks)2321
Completed2523
Not completed13
Withdrew: Consent withdrawn01
Withdrew: Other reasons for premature termination12

Outcome measures

PrimaryAUC(0-tz) of Unconjugated Rotigotine

The AUC(0-tz) is the area under the plasma concentration- time curve from zero up to the last analytically quantifiable concentration.

Time frame:
Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application
Reported as:
Mean · (ng/ mL)*h
AUC(0-tz) of Unconjugated Rotigotine
(ng/ mL)*hTreatment A (Test: PR2.1.1)Treatment B (Reference: PR1.0)
AUC(0-tz) of Unconjugated Rotigotine3.0168 ± 1.40773.0635 ± 1.4309
Statistical analysis
  • Treatment A (Test: PR2.1.1) vs Treatment B (Reference: PR1.0) · ANOVA · Ratio of geometric ls- means: 0.9864 · 90% CI 0.9103 to 1.0688Bioequivalence 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) and Cmax.
PrimaryCmax of Unconjugated Rotigotine

The Cmax is the maximum plasma concentration.

Time frame:
Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application.
Reported as:
Mean · ng/ mL
Cmax of Unconjugated Rotigotine
ng/ mLTreatment A (Test: PR2.1.1)Treatment B (Reference: PR1.0)
Cmax of Unconjugated Rotigotine0.14418 ± 0.062110.15155 ± 0.06540
Statistical analysis
  • Treatment A (Test: PR2.1.1) vs Treatment B (Reference: PR1.0) · ANOVA · Ratio of geometric ls- means: 0.9584 · 90% CI 0.8861 to 1.0367Bioequivalence 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) and Cmax.
SecondaryAUC(0-∞) of Unconjugated Rotigotine

The AUC(0-∞) is the area under the plasma concentration- time curve from zero up to infinity.

Time frame:
Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application.
Reported as:
Mean · (ng/ mL)*h
AUC(0-∞) of Unconjugated Rotigotine
(ng/ mL)*hTreatment A (Test: PR2.1.1)Treatment B (Reference: PR1.0)
AUC(0-∞) of Unconjugated Rotigotine3.12622 ± 1.415363.16403 ± 1.43028
Statistical analysis
  • Treatment A (Test: PR2.1.1) vs Treatment B (Reference: PR1.0) · ANOVA · Ratio of geometric ls- means: 0.9896 · 90% CI 0.9179 to 1.0671ANOVA for log- transformed values has been used as the basis for calculation of point estimates (LS- Means) and Confidence Intervals (CIs).
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:
Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application.
Reported as:
Mean · (ng/ mL)*(h/ mg)
AUC(0-tz)Norm (Apparent Dose) of Unconjugated Rotigotine
(ng/ mL)*(h/ mg)Treatment A (Test: PR2.1.1)Treatment B (Reference: PR1.0)
AUC(0-tz)Norm (Apparent Dose) of Unconjugated Rotigotine1.78200 ± 0.719121.58900 ± 0.54806
SecondaryAUC(0-tz)Norm (BW) 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:
Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application.
Reported as:
Mean · (ng/ mL)*h*kg
AUC(0-tz)Norm (BW) of Unconjugated Rotigotine
(ng/ mL)*h*kgTreatment A (Test: PR2.1.1)Treatment B (Reference: PR1.0)
AUC(0-tz)Norm (BW) of Unconjugated Rotigotine239.241 ± 112.475243.841 ± 116.640
SecondaryCmax,Norm (Apparent Dose) of Unconjugated Rotigotine

The Cmax,Norm (Apparent dose) is the maximum plasma concentration normalized by apparent dose.

Time frame:
Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application.
Reported as:
Mean · (ng/ mL) / mg
Cmax,Norm (Apparent Dose) of Unconjugated Rotigotine
(ng/ mL) / mgTreatment A (Test: PR2.1.1)Treatment B (Reference: PR1.0)
Cmax,Norm (Apparent Dose) of Unconjugated Rotigotine0.085822 ± 0.0327890.079619 ± 0.027178
SecondaryCmax,Norm (BW) of Unconjugated Rotigotine

The Cmax,Norm (BW) is the maximum plasma concentration normalized by body weight (kg).

Time frame:
Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application.
Reported as:
Mean · (ng/ mL)*kg
Cmax,Norm (BW) of Unconjugated Rotigotine
(ng/ mL)*kgTreatment A (Test: PR2.1.1)Treatment B (Reference: PR1.0)
Cmax,Norm (BW) of Unconjugated Rotigotine11.4391 ± 4.966712.0441 ± 5.3133
SecondaryTmax of Unconjugated Rotigotine

The Tmax is the time to reach a maximum plasma concentration after patch application.

Time frame:
Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application.
Reported as:
Median · hour (h)
Tmax of Unconjugated Rotigotine
hour (h)Treatment A (Test: PR2.1.1)Treatment B (Reference: PR1.0)
Tmax of Unconjugated Rotigotine16.00 ± 6.1816.00 ± 5.26
SecondaryMRT of Unconjugated Rotigotine

The MRT is the mean residence time.

Time frame:
Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24(before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application.
Reported as:
Mean · hour (h)
MRT of Unconjugated Rotigotine
hour (h)Treatment A (Test: PR2.1.1)Treatment B (Reference: PR1.0)
MRT of Unconjugated Rotigotine19.012 ± 1.80918.882 ± 1.802
Secondaryλz of Unconjugated Rotigotine

The λz is the rate constant of elimination.

Time frame:
Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application.
Reported as:
Mean · 1/ hour (1/h)
λz of Unconjugated Rotigotine
1/ hour (1/h)Treatment A (Test: PR2.1.1)Treatment B (Reference: PR1.0)
λz of Unconjugated Rotigotine0.153848 ± 0.0375250.151239 ± 0.025301
Secondaryt1/2 of Unconjugated Rotigotine

The t1/2 is the terminal half- life.

Time frame:
Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application.
Reported as:
Mean · hour (h)
t1/2 of Unconjugated Rotigotine
hour (h)Treatment A (Test: PR2.1.1)Treatment B (Reference: PR1.0)
t1/2 of Unconjugated Rotigotine4.7665 ± 1.14994.7128 ± 0.8088
SecondaryCL/f of Unconjugated Rotigotine

The CL/f is the apparent total body clearance.

Time frame:
Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application.
Reported as:
Mean · L/ h
CL/f of Unconjugated Rotigotine
L/ hTreatment A (Test: PR2.1.1)Treatment B (Reference: PR1.0)
CL/f of Unconjugated Rotigotine1825.38 ± 1058.211822.13 ± 1060.42
SecondaryApparent Dose

Apparent dose of unconjugated rotigotine in mg. The Apparent dose of unconjugated rotigotine was determined from the patches removed on Day 2.

Time frame:
48 hours
Reported as:
Mean · mg
Apparent Dose
mgTreatment A (Test: PR2.1.1)Treatment B (Reference: PR1.0)
Apparent Dose1.676 ± 0.4231.890 ± 0.561

Adverse events

Collected over Adverse Events (AEs) were collected within 48 hours.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Treatment A (Test: PR2.1.1)—0/51 (0%)21/51 (41.2%)
Treatment B (Reference: PR1.0)—0/51 (0%)21/51 (41.2%)
Most frequent other events
Showing 10 of 14
Most frequent other events
EventTreatment A (Test: PR2.1.1)Treatment B (Reference: PR1.0)
Application Site PruritusGeneral disorders12/5112/51
HeadacheNervous system disorders7/515/51
NauseaGastrointestinal disorders4/513/51
SomnolenceNervous system disorders2/513/51
DizzinessNervous system disorders0/513/51
VomitingGastrointestinal disorders2/511/51
Syncope VasovagalNervous system disorders2/510/51
Abnormal Sensation in EyeEye disorders1/511/51
Application Site Cold FeelingGeneral disorders1/510/51
FatigueGeneral disorders1/510/51

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Sequence A-B (Test: PR2.1.1 - Reference: PR1.0)Sequence B-A (Reference: PR1.0 - Test: PR2.1.1)Total
<=18 years000
Between 18 and 65 years232144
>=65 years000
Age, Continuous
Age, Continuous(years)Sequence A-B (Test: PR2.1.1 - Reference: PR1.0)Sequence B-A (Reference: PR1.0 - Test: PR2.1.1)Total
Mean38.7 ± 9.839.3 ± 9.139.0 ± 9.3
Sex: Female, Male
Sex: Female, Male(Participants)Sequence A-B (Test: PR2.1.1 - Reference: PR1.0)Sequence B-A (Reference: PR1.0 - Test: PR2.1.1)Total
Female000
Male232144
Region of Enrollment
Region of Enrollment(participants)Sequence A-B (Test: PR2.1.1 - Reference: PR1.0)Sequence B-A (Reference: PR1.0 - Test: PR2.1.1)Total
Germany232144
Weight
Weight(kg)Sequence A-B (Test: PR2.1.1 - Reference: PR1.0)Sequence B-A (Reference: PR1.0 - Test: PR2.1.1)Total
Mean78.98 ± 7.0879.98 ± 8.2079.45 ± 7.57
08

Study locations

1 site
  • Neuss, 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 Oct 27, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00881894
Lead sponsor
UCB Pharma
Responsible party
Sponsor
First posted
Apr 15, 2009
Start date
Oct 2008
Primary completion
Nov 2008
Completion
Dec 2008
Results posted
Dec 25, 2009
Last update
Oct 27, 2014

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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