Study in Healthy Volunteers to Prove That Two Rotigotine Patches From Different Manufacturing Sites Deliver Equivalent Drug Amount to the Body

• ClinicalTrials.gov Identifier: NCT00957944
• Recruitment Status: Completed
• First Posted: August 13, 2009
• Results First Posted: September 22, 2010
• Last Update Posted: October 27, 2014
• Sponsor: UCB Pharma
• Information provided by (Responsible Party): UCB Pharma

Study Description

Brief Summary:

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 sites.

Condition or disease	Intervention/treatment	Phase
Healthy Volunteers	Drug: rotigotine transdermal patch (Neupro®)	Phase 1

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 40 participants
• 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 (4.5 mg/10 cm^2) From 2 Different Manufacturing Sites.
• Study Start Date: July 2009
• Actual Primary Completion Date: August 2009
• Actual Study Completion Date: August 2009

Arms and Interventions

Arm	Intervention/treatment
Experimental: Sequence A-B (Test: PR 2.1.1 WCL - Reference: PR 2.1.1 AND); Two single applications of rotigotine patches from two different manufacturing sites in the order A-B separated by a washout phase of at least 5 days	Drug: rotigotine transdermal patch (Neupro®); Rotigotine 4.5 mg/10 cm^2 patch applied for 24 hours; Other Name: Neupro®
Experimental: Sequence B-A (Reference: PR 2.1.1 AND - Test: PR 2.1.1 WCL); Two single applications of rotigotine patches from two different manufacturing sites in the order B-A separated by a washout phase of at least 5 days	Drug: rotigotine transdermal patch (Neupro®); Rotigotine 4.5 mg/10 cm^2 patch applied for 24 hours; Other Name: Neupro®

Outcome Measures

Primary Outcome Measures :

1. 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. ]
   The AUC(0-tz) is the area under the plasma concentration- time curve from zero up to the last analytically quantifiable concentration.
2. 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. ]
   The Cmax is the maximum plasma concentration.
3. 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. ]
   The AUC(0-∞) is the area under the plasma concentration- time curve from zero up to infinity

Secondary Outcome Measures :

1. 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. ]
   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 (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. ]
   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: 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. ]
   The AUC(0-∞) 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 (BW) [ 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. ]
   The AUC(0-∞) 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: 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. ]
   The Cmax,norm (apparent dose) is the maximum plasma concentration normalized by apparent dose(mg).
6. 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. ]
   The Cmax,norm (BW) is the maximum plasma concentration normalized by body weight(kg).
7. 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. ]
   The tmax is the time to reach a maximum plasma concentration after patch application.
8. 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. ]
   The MRT is the mean residence time.
9. 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. ]
   The λz is the rate constant of elimination.
10. 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. ]
    The t1/2 is the terminal half- life.
11. 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. ]
    The CL/f is the apparent total body clearance.
12. Apparent Dose [ Time Frame: 48 hours ]
    Apparent dose of unconjugated rotigotine in mg. The apparent dose of unconjugated rotigotine was determined from the patches removed on Day 2.

Eligibility Criteria

• 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/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

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

Additional Information:

FDA Safety Alerts and Recalls 

• Responsible Party: UCB Pharma
• ClinicalTrials.gov Identifier: NCT00957944
• Other Study ID Numbers: SP0957
• First Posted: August 13, 2009
• Results First Posted: September 22, 2010
• Last Update Posted: October 27, 2014
• Last Verified: April 2012

Keywords provided by UCB Pharma:

Rotigotine; Neupro®

Additional relevant MeSH terms:

Rotigotine; Dopamine Agonists; Dopamine Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Physiological Effects of Drugs