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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:
ClinicalTrials.gov Identifier:
NCT00881894
First Posted: April 15, 2009
Last Update Posted: October 27, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
UCB Pharma
April 13, 2009
April 15, 2009
November 20, 2009
December 25, 2009
October 27, 2014
October 2008
November 2008   (Final data collection date for primary outcome measure)
  • 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 ]
    The AUC(0-tz) is the area under the plasma concentration- time curve from zero up to the last analytically quantifiable concentration.
  • 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. ]
    The Cmax is the maximum plasma concentration.
AUC(0-tz) of unconjugated rotigotine Cmax of unconjugated rotigotine [ Time Frame: 2 weeks ]
Complete list of historical versions of study NCT00881894 on ClinicalTrials.gov Archive Site
  • 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. ]
    The AUC(0-∞) is the area under the plasma concentration- time curve from zero up to infinity.
  • 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. ]
    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).
  • 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. ]
    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).
  • 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. ]
    The Cmax,Norm (Apparent dose) is the maximum plasma concentration normalized by apparent dose.
  • 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. ]
    The Cmax,Norm (BW) is the maximum plasma concentration normalized by body weight (kg).
  • 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. ]
    The Tmax is the time to reach a maximum plasma concentration after patch application.
  • 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. ]
    The MRT is the mean residence time.
  • 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. ]
    The λz is the rate constant of elimination.
  • 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. ]
    The t1/2 is the terminal half- life.
  • 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. ]
    The CL/f is the apparent total body clearance.
  • Apparent Dose [ Time Frame: 48 hours ]
    Apparent dose of unconjugated rotigotine in mg. The Apparent dose of unconjugated rotigotine was determined from the patches removed on Day 2.
  • AUC(0-tz)Norm (Apparent Dose) of Unconjugated Rotigotine [ Time Frame: 2 weeks ]
  • AUC(0-tz)Norm (BW) of Unconjugated Rotigotine [ Time Frame: 2 weeks ]
  • AUC(0-∞) of Unconjugated Rotigotine [ Time Frame: 2 weeks ]
  • Cmax,Norm (Apparent Dose) of Unconjugated Rotigotine [ Time Frame: 2 weeks ]
  • Cmax,norm (BW) of unconjugated rotigotine tmax of unconjugated rotigotine [ Time Frame: 2 weeks ]
  • MRT of Unconjugated Rotigotine [ Time Frame: 2 weeks ]
  • λz of Unconjugated Rotigotine [ Time Frame: 2 weeks ]
  • t1/2 of Unconjugated Rotigotine [ Time Frame: 2 weeks ]
  • fCmax of unconjugated rotigotine [ Time Frame: 2 weeks ]
  • fAUC of unconjugated rotigotine [ Time Frame: 2 weeks ]
  • CL/f of Unconjugated Rotigotine [ Time Frame: 2 weeks ]
  • Apparent Dose [ Time Frame: 2 weeks ]
Not Provided
Not Provided
 
Study in Healthy Volunteers to Prove That 2 Rotigotine Patches From Different Manufacturing Processes 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/10cm^2) From 2 Different Manufacturing Processes
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.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Healthy
Drug: Rotigotine transdermal patch
Rotigotine 4.5mg/10cm^2 patch applied for 24 hours
Other Name: Neupro®
  • 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
    Intervention: 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
    Intervention: Drug: Rotigotine transdermal patch
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
52
December 2008
November 2008   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Healthy White, male volunteers between 18 and 55 years of age (inclusive).
  • BMI between 19 and 28 kg/m² (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.
  • Thickly hair-covered abdomen resulting in difficulties in finding appropriate patch application sites
Sexes Eligible for Study: Male
18 Years to 55 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Germany
 
 
NCT00881894
SP0951
No
Not Provided
Not Provided
UCB Pharma
UCB Pharma
Not Provided
Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
UCB Pharma
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP