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

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.

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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: rotigotine transdermal patch (Neupro®)

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 1

Contacts and Locations

Study Locations

• Germany
  • NRW
    • Neuss, NRW, Germany

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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 Names: Neupro®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AUC(0-tz) of Unconjugated Rotigotine	The AUC(0-tz) is the area under the plasma concentration- time curve from zero up to the last analytically quantifiable concentration.	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.
Cmax of Unconjugated Rotigotine	The Cmax is the maximum plasma concentration.	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.
AUC(0-∞) of Unconjugated Rotigotine	The AUC(0-∞) is the area under the plasma concentration- time curve from zero up to infinity	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.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AUC(0-tz) Norm (Apparent Dose) of Unconjugated Rotigotine	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).	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.
AUC(0-tz) Norm (BW) of Unconjugated Rotigotine	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).	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.
AUC(0-∞) Norm (Apparent Dose)	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).	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.
AUC(0-∞) Norm (BW)	The AUC(0-∞) norm (BW) is the area under the plasma concentration- time curve from zero up to infinity normalized by body weight (kg).	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.
Cmax,Norm (Apparent Dose) of Unconjugated Rotigotine	The Cmax,norm (apparent dose) is the maximum plasma concentration normalized by apparent dose(mg).	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.
Cmax,Norm (BW) of Unconjugated Rotigotine	The Cmax,norm (BW) is the maximum plasma concentration normalized by body weight(kg).	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.
Tmax of Unconjugated Rotigotine	The tmax is the time to reach a maximum plasma concentration after patch application.	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.
MRT of Unconjugated Rotigotine	The MRT is the mean residence time.	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.
λz of Unconjugated Rotigotine	The λz is the rate constant of elimination.	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.
t1/2 of Unconjugated Rotigotine	The t1/2 is the terminal half- life.	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.
CL/f of Unconjugated Rotigotine	The CL/f is the apparent total body clearance.	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.
Apparent Dose	Apparent dose of unconjugated rotigotine in mg. The apparent dose of unconjugated rotigotine was determined from the patches removed on Day 2.	48 hours

Collaborators and Investigators

• Sponsor: UCB Pharma

Publications and helpful links

Helpful Links

• FDA Safety Alerts and Recalls

Study record dates

Study Major Dates

• Study Start: July 1, 2009
• Primary Completion (Actual): August 1, 2009
• Study Completion (Actual): August 1, 2009

Study Registration Dates

• First Submitted: August 11, 2009
• First Submitted That Met QC Criteria: August 12, 2009
• First Posted (Estimate): August 13, 2009

Study Record Updates

• Last Update Posted (Estimate): October 27, 2014
• Last Update Submitted That Met QC Criteria: October 17, 2014
• Last Verified: April 1, 2012

More Information

Terms related to this study

• Keywords: Rotigotine; Neupro®
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Dopamine Agonists; Dopamine Agents; Rotigotine
• Other Study ID Numbers: SP0957