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
  Purpose

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.


Condition Intervention Phase
Healthy
Drug: Rotigotine transdermal patch
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: 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

Resource links provided by NLM:


Further study details as provided by UCB Pharma:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 52
Study Start Date: October 2008
Study Completion Date: December 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Rotigotine 4.5mg/10cm^2 patch applied for 24 hours
Other Name: Neupro®
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
Rotigotine 4.5mg/10cm^2 patch applied for 24 hours
Other Name: Neupro®

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00881894

Locations
Germany
Neuss, NRW, Germany
Sponsors and Collaborators
UCB Pharma
Investigators
Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
  More Information

No publications provided by UCB Pharma

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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

Keywords provided by UCB Pharma:
Rotigotine
Neupro®
Transdermal Patch

Additional relevant MeSH terms:
N 0437
Dopamine Agents
Dopamine Agonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 23, 2014