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 Pharma
ClinicalTrials.gov Identifier:
NCT00881894
First received: April 13, 2009
Last updated: May 15, 2012
Last verified: May 2012
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Consent withdrawn                 0                 1  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
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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.
No text entered.

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 ]

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. ]

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. ]

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. ]

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. ]

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. ]

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. ]

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. ]

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. ]

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. ]

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. ]

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. ]

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


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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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.


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


No publications provided by UCB Pharma

Publications automatically indexed to this study:

Responsible Party: UCB Pharma
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