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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
UCB, Inc.
ClinicalTrials.gov Identifier:
NCT00881894
First received: April 13, 2009
Last updated: May 15, 2012
Last verified: May 2012
History of Changes
Results First Received: November 20, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Bio-equivalence Study;   Intervention Model: Crossover Assignment;   Masking: Open Label;   Primary Purpose: Basic Science
Condition: Healthy
Intervention: Drug: Rotigotine transdermal patch

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Patients with an insufficient patch adhesiveness were excluded from the PKS.

Reporting Groups
  Description
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
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

Participant Flow:   Overall Study
    Sequence A-B (Test: PR2.1.1 - Reference: PR1.0)     Sequence B-A (Reference: PR1.0 - Test: PR2.1.1)  
STARTED     26     26  
Pharmacokinetic Set (PKS)     23 [1]   21 [1]
COMPLETED     25     23  
NOT COMPLETED     1     3  
Consent withdrawn                 0                 1  
Other reasons for premature termination                 1                 2  
[1] Patients with an insufficient patch adhesiveness were excluded from the PKS.



  Baseline Characteristics
  Hide Baseline Characteristics

Reporting Groups
  Description
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
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
Total Total of all reporting groups

Baseline Measures
    Sequence A-B (Test: PR2.1.1 - Reference: PR1.0)     Sequence B-A (Reference: PR1.0 - Test: PR2.1.1)     Total  
Number of Participants  
[units: participants]
 		  23     21     44  
Age  
[units: participants]
 		     
<=18 years     0     0     0  
Between 18 and 65 years     23     21     44  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation 		  38.7  ± 9.8     39.3  ± 9.1     39.0  ± 9.3  
Gender  
[units: participants]
 		     
Female     0     0     0  
Male     23     21     44  
Region of Enrollment  
[units: participants]
 		     
Germany     23     21     44  
Weight  
[units: kg]
Mean ± Standard Deviation 		  78.98  ± 7.08     79.98  ± 8.20     79.45  ± 7.57  



  Outcome Measures
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1.  Primary:   AUC(0-tz) of Unconjugated Rotigotine   [ 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 ]

Measure Type Primary
Measure Title AUC(0-tz) of Unconjugated Rotigotine
Measure Description 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  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Pharmacokinetic Set (PKS)

Reporting Groups
  Description
Treatment A (Test: PR2.1.1) Rotigotine transdermal patch (4.5 mg/ 10 cm^2) from modified manufacturing process (Test; drug product PR2.1.1); single application of 1 patch for 24 hours
Treatment B (Reference: PR1.0) Rotigotine transdermal patch (4.5 mg/ 10 cm^2) from originally approved manufacturing process (Reference; drug product PR1.0); single application of 1 patch for 24 hours

Measured Values
    Treatment A (Test: PR2.1.1)     Treatment B (Reference: PR1.0)  
Number of Participants Analyzed  
[units: participants]
 		  44     44  
AUC(0-tz) of Unconjugated Rotigotine  
[units: (ng/ mL)*h]
Mean ± Standard Deviation 		  3.0168  ± 1.4077     3.0635  ± 1.4309  


Statistical Analysis 1 for AUC(0-tz) of Unconjugated Rotigotine
Groups [1] All groups
Non-Inferiority/Equivalence Test [2] Yes
ratio of geometric LS- Means [3] 0.9864
90% Confidence Interval ( 0.9103 to 1.0688 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Bioequivalence testing by using the 90% Confidence Interval (CI).
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  If the 90% Confidence Interval for the ratio of geometric LS- Means is included within 0.8- 1.25, the patches are considered bioequivalent.
[3] Other relevant estimation information:
  Bioequivalence 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.



2.  Primary:   Cmax of Unconjugated Rotigotine   [ 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. ]

Measure Type Primary
Measure Title Cmax of Unconjugated Rotigotine
Measure Description 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.  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Pharmacokinetic Set (PKS)

Reporting Groups
  Description
Treatment A (Test: PR2.1.1) Rotigotine transdermal patch (4.5 mg/ 10 cm^2) from modified manufacturing process (Test; drug product PR2.1.1); single application of 1 patch for 24 hours
Treatment B (Reference: PR1.0) Rotigotine transdermal patch (4.5 mg/ 10 cm^2) from originally approved manufacturing process (Reference; drug product PR1.0); single application of 1 patch for 24 hours

Measured Values
    Treatment A (Test: PR2.1.1)     Treatment B (Reference: PR1.0)  
Number of Participants Analyzed  
[units: participants]
 		  44     44  
Cmax of Unconjugated Rotigotine  
[units: ng/ mL]
Mean ± Standard Deviation 		  0.14418  ± 0.06211     0.15155  ± 0.06540  


Statistical Analysis 1 for Cmax of Unconjugated Rotigotine
Groups [1] All groups
Non-Inferiority/Equivalence Test [2] Yes
ratio of geometric LS- Means [3] 0.9584
90% Confidence Interval ( 0.8861 to 1.0367 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Bioequivalence testing by using the 90% Confidence Interval (CI).
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  If the 90% Confidence Interval for the ratio of geometric LS- Means is included within 0.8- 1.25, the patches are considered bioequivalent.
[3] Other relevant estimation information:
  Bioequivalence 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.



3.  Secondary:   AUC(0-∞) of Unconjugated Rotigotine   [ 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. ]

Measure Type Secondary
Measure Title AUC(0-∞) of Unconjugated Rotigotine
Measure Description 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.  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Pharmacokinetic Set (PKS)

Reporting Groups
  Description
Treatment A (Test: PR2.1.1) Rotigotine transdermal patch (4.5 mg/ 10 cm^2) from modified manufacturing process (Test; drug product PR2.1.1); single application of 1 patch for 24 hours
Treatment B (Reference: PR1.0) Rotigotine transdermal patch (4.5 mg/ 10 cm^2) from originally approved manufacturing process (Reference; drug product PR1.0); single application of 1 patch for 24 hours

Measured Values
    Treatment A (Test: PR2.1.1)     Treatment B (Reference: PR1.0)  
Number of Participants Analyzed  
[units: participants]
 		  44     44  
AUC(0-∞) of Unconjugated Rotigotine  
[units: (ng/ mL)*h]
Mean ± Standard Deviation 		  3.12622  ± 1.41536     3.16403  ± 1.43028  


Statistical Analysis 1 for AUC(0-∞) of Unconjugated Rotigotine
Groups [1] All groups
Non-Inferiority/Equivalence Test [2] Yes
ratio of geometric LS- Means [3] 0.9896
90% Confidence Interval ( 0.9179 to 1.0671 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Bioequivalence testing by using the 90% Confidence Interval (CI).
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  If the 90% Confidence Interval for the ratio of geometric LS- Means is included within 0.8- 1.25, the patches are considered bioequivalent.
[3] Other relevant estimation information:
  No text entered.



4.  Secondary:   AUC(0-tz)Norm (Apparent Dose) of Unconjugated Rotigotine   [ 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. ]

Measure Type Secondary
Measure Title AUC(0-tz)Norm (Apparent Dose) of Unconjugated Rotigotine
Measure Description 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.  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Pharmacokinetic Set (PKS)

Reporting Groups
  Description
Treatment A (Test: PR2.1.1) Rotigotine transdermal patch (4.5 mg/ 10 cm^2) from modified manufacturing process (Test; drug product PR2.1.1); single application of 1 patch for 24 hours
Treatment B (Reference: PR1.0) Rotigotine transdermal patch (4.5 mg/ 10 cm^2) from originally approved manufacturing process (Reference; drug product PR1.0); single application of 1 patch for 24 hours

Measured Values
    Treatment A (Test: PR2.1.1)     Treatment B (Reference: PR1.0)  
Number of Participants Analyzed  
[units: participants]
 		  44     44  
AUC(0-tz)Norm (Apparent Dose) of Unconjugated Rotigotine  
[units: (ng/ mL)*(h/ mg)]
Mean ± Standard Deviation 		  1.78200  ± 0.71912     1.58900  ± 0.54806  

No statistical analysis provided for AUC(0-tz)Norm (Apparent Dose) of Unconjugated Rotigotine



5.  Secondary:   AUC(0-tz)Norm (BW) of Unconjugated Rotigotine   [ 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. ]

Measure Type Secondary
Measure Title AUC(0-tz)Norm (BW) of Unconjugated Rotigotine
Measure Description 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.  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Pharmacokinetic Set (PKS)

Reporting Groups
  Description
Treatment A (Test: PR2.1.1) Rotigotine transdermal patch (4.5 mg/ 10 cm^2) from modified manufacturing process (Test; drug product PR2.1.1); single application of 1 patch for 24 hours
Treatment B (Reference: PR1.0) Rotigotine transdermal patch (4.5 mg/ 10 cm^2) from originally approved manufacturing process (Reference; drug product PR1.0); single application of 1 patch for 24 hours

Measured Values
    Treatment A (Test: PR2.1.1)     Treatment B (Reference: PR1.0)  
Number of Participants Analyzed  
[units: participants]
 		  44     44  
AUC(0-tz)Norm (BW) of Unconjugated Rotigotine  
[units: (ng/ mL)*h*kg]
Mean ± Standard Deviation 		  239.241  ± 112.475     243.841  ± 116.640  

No statistical analysis provided for AUC(0-tz)Norm (BW) of Unconjugated Rotigotine



6.  Secondary:   Cmax,Norm (Apparent Dose) of Unconjugated Rotigotine   [ 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. ]

Measure Type Secondary
Measure Title Cmax,Norm (Apparent Dose) of Unconjugated Rotigotine
Measure Description 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.  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Pharmacokinetic Set (PKS)

Reporting Groups
  Description
Treatment A (Test: PR2.1.1) Rotigotine transdermal patch (4.5 mg/ 10 cm^2) from modified manufacturing process (Test; drug product PR2.1.1); single application of 1 patch for 24 hours
Treatment B (Reference: PR1.0) Rotigotine transdermal patch (4.5 mg/ 10 cm^2) from originally approved manufacturing process (Reference; drug product PR1.0); single application of 1 patch for 24 hours

Measured Values
    Treatment A (Test: PR2.1.1)     Treatment B (Reference: PR1.0)  
Number of Participants Analyzed  
[units: participants]
 		  44     44  
Cmax,Norm (Apparent Dose) of Unconjugated Rotigotine  
[units: (ng/ mL) / mg]
Mean ± Standard Deviation 		  0.085822  ± 0.032789     0.079619  ± 0.027178  

No statistical analysis provided for Cmax,Norm (Apparent Dose) of Unconjugated Rotigotine



7.  Secondary:   Cmax,Norm (BW) of Unconjugated Rotigotine   [ 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. ]

Measure Type Secondary
Measure Title Cmax,Norm (BW) of Unconjugated Rotigotine
Measure Description 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.  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Pharmacokinetic Set (PKS)

Reporting Groups
  Description
Treatment A (Test: PR2.1.1) Rotigotine transdermal patch (4.5 mg/ 10 cm^2) from modified manufacturing process (Test; drug product PR2.1.1); single application of 1 patch for 24 hours
Treatment B (Reference: PR1.0) Rotigotine transdermal patch (4.5 mg/ 10 cm^2) from originally approved manufacturing process (Reference; drug product PR1.0); single application of 1 patch for 24 hours

Measured Values
    Treatment A (Test: PR2.1.1)     Treatment B (Reference: PR1.0)  
Number of Participants Analyzed  
[units: participants]
 		  44     44  
Cmax,Norm (BW) of Unconjugated Rotigotine  
[units: (ng/ mL)*kg]
Mean ± Standard Deviation 		  11.4391  ± 4.9667     12.0441  ± 5.3133  

No statistical analysis provided for Cmax,Norm (BW) of Unconjugated Rotigotine



8.  Secondary:   Tmax of Unconjugated Rotigotine   [ 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. ]

Measure Type Secondary
Measure Title Tmax of Unconjugated Rotigotine
Measure Description 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.  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Pharmacokinetic Set (PKS)

Reporting Groups
  Description
Treatment A (Test: PR2.1.1) Rotigotine transdermal patch (4.5 mg/ 10 cm^2) from modified manufacturing process (Test; drug product PR2.1.1); single application of 1 patch for 24 hours
Treatment B (Reference: PR1.0) Rotigotine transdermal patch (4.5 mg/ 10 cm^2) from originally approved manufacturing process (Reference; drug product PR1.0); single application of 1 patch for 24 hours

Measured Values
    Treatment A (Test: PR2.1.1)     Treatment B (Reference: PR1.0)  
Number of Participants Analyzed  
[units: participants]
 		  44     44  
Tmax of Unconjugated Rotigotine  
[units: hour (h)]
Median ( Full Range ) 		  16.00  
  ( 8.0 to 28.0 )   		  16.00  
  ( 6.0 to 26.0 )  

No statistical analysis provided for Tmax of Unconjugated Rotigotine



9.  Secondary:   MRT of Unconjugated Rotigotine   [ 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. ]

Measure Type Secondary
Measure Title MRT of Unconjugated Rotigotine
Measure Description 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.  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Pharmacokinetic Set (PKS)

Reporting Groups
  Description
Treatment A (Test: PR2.1.1) Rotigotine transdermal patch (4.5 mg/ 10 cm^2) from modified manufacturing process (Test; drug product PR2.1.1); single application of 1 patch for 24 hours
Treatment B (Reference: PR1.0) Rotigotine transdermal patch (4.5 mg/ 10 cm^2) from originally approved manufacturing process (Reference; drug product PR1.0); single application of 1 patch for 24 hours

Measured Values
    Treatment A (Test: PR2.1.1)     Treatment B (Reference: PR1.0)  
Number of Participants Analyzed  
[units: participants]
 		  44     44  
MRT of Unconjugated Rotigotine  
[units: hour (h)]
Mean ± Standard Deviation 		  19.012  ± 1.809     18.882  ± 1.802  

No statistical analysis provided for MRT of Unconjugated Rotigotine



10.  Secondary:   λz of Unconjugated Rotigotine   [ 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. ]

Measure Type Secondary
Measure Title λz of Unconjugated Rotigotine
Measure Description 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.  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Pharmacokinetic Set (PKS)

Reporting Groups
  Description
Treatment A (Test: PR2.1.1) Rotigotine transdermal patch (4.5 mg/ 10 cm^2) from modified manufacturing process (Test; drug product PR2.1.1); single application of 1 patch for 24 hours
Treatment B (Reference: PR1.0) Rotigotine transdermal patch (4.5 mg/ 10 cm^2) from originally approved manufacturing process (Reference; drug product PR1.0); single application of 1 patch for 24 hours

Measured Values
    Treatment A (Test: PR2.1.1)     Treatment B (Reference: PR1.0)  
Number of Participants Analyzed  
[units: participants]
 		  44     44  
λz of Unconjugated Rotigotine  
[units: 1/ hour (1/h)]
Mean ± Standard Deviation 		  0.153848  ± 0.037525     0.151239  ± 0.025301  

No statistical analysis provided for λz of Unconjugated Rotigotine



11.  Secondary:   t1/2 of Unconjugated Rotigotine   [ 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. ]

Measure Type Secondary
Measure Title t1/2 of Unconjugated Rotigotine
Measure Description 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.  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Pharmacokinetic Set (PKS)

Reporting Groups
  Description
Treatment A (Test: PR2.1.1) Rotigotine transdermal patch (4.5 mg/ 10 cm^2) from modified manufacturing process (Test; drug product PR2.1.1); single application of 1 patch for 24 hours
Treatment B (Reference: PR1.0) Rotigotine transdermal patch (4.5 mg/ 10 cm^2) from originally approved manufacturing process (Reference; drug product PR1.0); single application of 1 patch for 24 hours

Measured Values
    Treatment A (Test: PR2.1.1)     Treatment B (Reference: PR1.0)  
Number of Participants Analyzed  
[units: participants]
 		  44     44  
t1/2 of Unconjugated Rotigotine  
[units: hour (h)]
Mean ± Standard Deviation 		  4.7665  ± 1.1499     4.7128  ± 0.8088  

No statistical analysis provided for t1/2 of Unconjugated Rotigotine



12.  Secondary:   CL/f of Unconjugated Rotigotine   [ 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. ]

Measure Type Secondary
Measure Title CL/f of Unconjugated Rotigotine
Measure Description 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.  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Pharmacokinetic Set (PKS)

Reporting Groups
  Description
Treatment A (Test: PR2.1.1) Rotigotine transdermal patch (4.5 mg/ 10 cm^2) from modified manufacturing process (Test; drug product PR2.1.1); single application of 1 patch for 24 hours
Treatment B (Reference: PR1.0) Rotigotine transdermal patch (4.5 mg/ 10 cm^2) from originally approved manufacturing process (Reference; drug product PR1.0); single application of 1 patch for 24 hours

Measured Values
    Treatment A (Test: PR2.1.1)     Treatment B (Reference: PR1.0)  
Number of Participants Analyzed  
[units: participants]
 		  44     44  
CL/f of Unconjugated Rotigotine  
[units: L/ h]
Mean ± Standard Deviation 		  1825.38  ± 1058.21     1822.13  ± 1060.42  

No statistical analysis provided for CL/f of Unconjugated Rotigotine



13.  Secondary:   Apparent Dose   [ Time Frame: 48 hours ]

Measure Type Secondary
Measure Title Apparent Dose
Measure Description 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  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Pharmacokinetic Set (PKS)

Reporting Groups
  Description
Treatment A (Test: PR2.1.1) Rotigotine transdermal patch (4.5 mg/ 10 cm^2) from modified manufacturing process (Test; drug product PR2.1.1); single application of 1 patch for 24 hours
Treatment B (Reference: PR1.0) Rotigotine transdermal patch (4.5 mg/ 10 cm^2) from originally approved manufacturing process (Reference; drug product PR1.0); single application of 1 patch for 24 hours

Measured Values
    Treatment A (Test: PR2.1.1)     Treatment B (Reference: PR1.0)  
Number of Participants Analyzed  
[units: participants]
 		  44     44  
Apparent Dose  
[units: mg]
Mean ± Standard Deviation 		  1.676  ± 0.423     1.890  ± 0.561  

No statistical analysis provided for Apparent Dose




  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: UCB Clinical Trial Call Center
Organization: UCB
phone: +1 877 822 9493


No publications provided


Responsible Party: UCB, Inc.
ClinicalTrials.gov Identifier: NCT00881894     History of Changes
Other Study ID Numbers: SP951
Study First Received: April 13, 2009
Results First Received: November 20, 2009
Last Updated: May 15, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices