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Completed

NCT Number: NCT01059903

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

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

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Key information

Conditions

Healthy Volunteers

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Mönchengladbach, North Rhine-Westphalia, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rotigotine transdermal patch

Drug

Rotigotine 4.5 mg/10 cm^2 patch applied for 24 hours

Other names: Neupro®

Primary outcomes

  1. 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.

  2. 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.

  3. 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 outcomes

  1. 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).

  2. 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).

  3. 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).

  4. 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).

  5. 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).

  6. 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).

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

Sponsors and collaborators

Lead sponsor

UCB Pharma

Industry

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Feb 1, 2010
Registry last updated
May 22, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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