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Study in Healthy Volunteers to Prove That Two Different Formulations of Rotigotine Patches Deliver Equivalent Drug Amount to the Body

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01059903
First Posted: February 1, 2010
Last Update Posted: May 23, 2012
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
  Purpose
The major aim of this study is to investigate and compare the drug amount delivered to the body after sequential application of two Rotigotine patches of two different formulations

Condition Intervention Phase
Healthy Volunteers Drug: Rotigotine transdermal patch Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (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/10cm2) Comparing Two Different Formulations

Resource links provided by NLM:


Further study details as provided by UCB Pharma:

Primary Outcome Measures:
  • AUC(0-tz) of Unconjugated Rotigotine [ Time Frame: 0 h (predose), 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 16 h, 24 h (before patch removal in the morning of Day 2), 25 h, 26 h, 28 h, 30 h, 32 h, 36 h, 40 h, and 48 h ]
    The AUC(0-tz) is the area under the concentration-time curve from zero up to the last analytically quantifiable concentration.

  • Cmax of Unconjugated Rotigotine [ Time Frame: 0 h (predose), 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 16 h, 24 h (before patch removal in the morning of Day 2), 25 h, 26 h, 28 h, 30 h, 32 h, 36 h, 40 h, and 48 h ]
    The Cmax is the maximum plasma concentration.

  • AUC(0- ∞) of Unconjugated Rotigotine [ Time Frame: 0 h (predose), 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 16 h, 24 h (before patch removal in the morning of Day 2), 25 h, 26 h, 28 h, 30 h, 32 h, 36 h, 40 h, and 48 h ]
    The AUC(0- ∞) is the area under the plasma concentration-time curve from zero up to infinity


Secondary Outcome Measures:
  • AUC(0-tz) Norm (Apparent Dose) of Unconjugated Rotigotine [ Time Frame: 0 h (predose), 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 16 h, 24 h (before patch removal in the morning of Day 2), 25 h, 26 h, 28 h, 30 h, 32 h, 36 h, 40 h, and 48 h ]
    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 (Body Weight) of Unconjugated Rotigotine [ Time Frame: 0 h (predose), 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 16 h, 24 h (before patch removal in the morning of Day 2), 25 h, 26 h, 28 h, 30 h, 32 h, 36 h, 40 h, and 48 h ]
    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).

  • AUC(0- ∞) Norm (Apparent Dose) [ Time Frame: 0 h (predose), 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 16 h, 24 h (before patch removal in the morning of Day 2), 25 h, 26 h, 28 h, 30 h, 32 h, 36 h, 40 h, and 48 h ]
    The AUC(0-inf) norm (apparent dose) is the area under the plasma concentration-time curve from zero up to infinity normalized by apparent dose (mg).

  • AUC(0- ∞) Norm (Body Weight) [ Time Frame: 0 h (predose), 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 16 h, 24 h (before patch removal in the morning of Day 2), 25 h, 26 h, 28 h, 30 h, 32 h, 36 h, 40 h, and 48 h ]
    The AUC(0-inf) norm (BW) is the area under the plasma concentration-time curve from zero up to infinity normalized by body weight (kg).

  • Cmax, Norm (Apparent Dose) of Unconjugated Rotigotine [ Time Frame: 0 h (predose), 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 16 h, 24 h (before patch removal in the morning of Day 2), 25 h, 26 h, 28 h, 30 h, 32 h, 36 h, 40 h, and 48 h ]
    The Cmax, norm (apparent dose) is the maximum plasma concentration normalized by apparent dose (mg).

  • Cmax, Norm (Body Weight) of Unconjugated Rotigotine [ Time Frame: 0 h (predose), 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 16 h, 24 h (before patch removal in the morning of Day 2), 25 h, 26 h, 28 h, 30 h, 32 h, 36 h, 40 h, and 48 h ]
    The Cmax, norm (BW) is the maximum plasma concentration normalized by body weight (kg).

  • Tmax of Unconjugated Rotigotine [ Time Frame: 0 h (predose), 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 16 h, 24 h (before patch removal in the morning of Day 2), 25 h, 26 h, 28 h, 30 h, 32 h, 36 h, 40 h, and 48 h ]
    The tmax is the time to reach maximum plasma concentration after patch application.

  • Mean Residence Time (MRT) of Unconjugated Rotigotine [ Time Frame: 0 h (predose), 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 16 h, 24 h (before patch removal in the morning of Day 2), 25 h, 26 h, 28 h, 30 h, 32 h, 36 h, 40 h, and 48 h ]
    The MRT is the mean residence time.

  • Rate Constant of Elimination (λz) of Unconjugated Rotigotine [ Time Frame: 0 h (predose), 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 16 h, 24 h (before patch removal in the morning of Day 2), 25 h, 26 h, 28 h, 30 h, 32 h, 36 h, 40 h, and 48 h ]
    The λz of unconjugated rotigotine is the rate constant of elimination.

  • Terminal Half-Life (t1/2) of Unconjugated Rotigotine [ Time Frame: 0 h (predose), 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 16 h, 24 h (before patch removal in the morning of Day 2), 25 h, 26 h, 28 h, 30 h, 32 h, 36 h, 40 h, and 48 h ]
    the t1/2 of unconjugated rotigotine is the terminal half-life, calculated as t1/2=ln2/ λz.

  • Apparent Total Body Clearance (CL/f) of Unconjugated Rotigotine [ Time Frame: 0 h (predose), 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 16 h, 24 h (before patch removal in the morning of Day 2), 25 h, 26 h, 28 h, 30 h, 32 h, 36 h, 40 h, and 48 h ]
    The CL/f of unconjugated rotigotine is the apparent total body clearance.

  • Apparent Dose [ Time Frame: 24 hours ]
    Apparent dose of unconjugated rotigotine in mg. The apparent dose was calculated by subtraction of the determined residual content of each rotigotine patch from the nominal content of rotigotine in the patch.


Enrollment: 50
Study Start Date: January 2010
Study Completion Date: March 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Rotigotine PR2.2.1 first
Rotigotine transdermal patch 4.5 mg/10 cm^2, test drug product PR2.2.1 followed by Rotigotine transdermal patch 4.5 mg/10 cm^2, reference drug product PR2.1.1 separated by a washout phase of at least 5 days
Drug: Rotigotine transdermal patch
Rotigotine 4.5 mg/10 cm^2 patch applied for 24 hours
Other Name: Neupro®
Experimental: Rotigotine PR2.1.1 first
Rotigotine transdermal patch 4.5 mg/10 cm^2, reference drug product PR2.1.1 followed by Rotigotine transdermal patch 4.5 mg/10 cm^2, test drug product PR2.2.1 separated by a washout phase of at least 5 days
Drug: Rotigotine transdermal patch
Rotigotine 4.5 mg/10 cm^2 patch applied for 24 hours
Other Name: Neupro®

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes 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/m^2 (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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01059903


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

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: UCB Pharma
ClinicalTrials.gov Identifier: NCT01059903     History of Changes
Other Study ID Numbers: SP0987
First Submitted: January 28, 2010
First Posted: February 1, 2010
Results First Submitted: February 4, 2011
Results First Posted: March 3, 2011
Last Update Posted: May 23, 2012
Last Verified: May 2012

Keywords provided by UCB Pharma:
Rotigotine
Neupro®
Transdermal Patch

Additional relevant MeSH terms:
Rotigotine
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs