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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-07-31

Study Completion Date

2009-08-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

rotigotine transdermal patch (Neupro®)

Intervention Type DRUG

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

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

Group Type EXPERIMENTAL

rotigotine transdermal patch (Neupro®)

Intervention Type DRUG

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

Interventions

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rotigotine transdermal patch (Neupro®)

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

Intervention Type DRUG

Other Intervention Names

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Neupro®

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes