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

April 13, 2009
May 15, 2012
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 ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    The Cmax is the maximum plasma concentration.
AUC(0-tz) of unconjugated rotigotine Cmax of unconjugated rotigotine [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    The CL/f is the apparent total body clearance.
  • Apparent Dose [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • AUC(0-tz) norm (BW) of unconjugated rotigotine [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
  • AUC(0-∞) of unconjugated rotigotine [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
  • Cmax,norm (apparent dose) of unconjugated rotigotine [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
  • Cmax,norm (BW) of unconjugated rotigotine tmax of unconjugated rotigotine [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
  • MRT of unconjugated rotigotine [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
  • λz of unconjugated rotigotine [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
  • t1/2 of unconjugated rotigotine [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
  • fCmax of unconjugated rotigotine [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
  • fAUC of unconjugated rotigotine [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
  • CL/f of unconjugated rotigotine [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
  • Apparent dose [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
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
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: 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
Male
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00881894
SP951
No
UCB, Inc.
UCB, Inc.
Not Provided
Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
UCB, Inc.
May 2012

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