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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:
Information provided by (Responsible Party):
UCB, Inc.
ClinicalTrials.gov Identifier:
NCT01059903
First received: January 28, 2010
Last updated: May 15, 2012
Last verified: May 2012
History of Changes
  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
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/10cm2) Comparing Two Different Formulations

Resource links provided by NLM:

Drug Information available for: Rotigotine
U.S. FDA Resources

Further study details as provided by UCB, Inc.:

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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ 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 (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 ] [ 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).

  • 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ 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: 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    The CL/f of unconjugated rotigotine is the apparent total body clearance.

  • Apparent Dose [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    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

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/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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01059903

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

Additional Information:
Product Information  This link exits the ClinicalTrials.gov site
FDA Safety Alerts and Recalls  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: UCB, Inc.
ClinicalTrials.gov Identifier: NCT01059903     History of Changes
Other Study ID Numbers: SP0987
Study First Received: January 28, 2010
Results First Received: February 4, 2011
Last Updated: May 15, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by UCB, Inc.:
Rotigotine
Neupro®
Transdermal Patch

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

ClinicalTrials.gov processed this record on May 23, 2013