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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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 Form

Brief Summary: 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

Detailed Summary:
Sponsor: UCB Pharma

Current Primary Outcome:

  • 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


Original Primary Outcome:

  • 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 ]
  • 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 ]
  • 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 ]


Current Secondary Outcome:

  • 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.


Original Secondary Outcome:

  • 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 ]
  • AUC(0-tz) Norm (BW) 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 ]
  • 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 ]
  • AUC(0- ∞) Norm (BW) [ 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 ]
  • 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 ]
  • Cmax, Norm (BW) 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • Apparent Dose [ Time Frame: 24 hours ]


Information By: UCB Pharma

Dates:
Date Received: January 28, 2010
Date Started: January 2010
Date Completion:
Last Updated: May 15, 2012
Last Verified: May 2012