Study in Healthy Volunteers to Prove That 2 Rotigotine Patches From Different Manufacturing Processes 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

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

Study Completion Date

2008-12-31

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 processes.

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Detailed Description

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Conditions

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Healthy

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: PR2.1.1 - Reference: PR1.0)

Two single applications of rotigotine patches from two different manufacturing processes in the order A-B separated by a washout phase of at least 5 days

Group Type EXPERIMENTAL

Rotigotine transdermal patch

Intervention Type DRUG

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

Sequence B-A (Reference: PR1.0 - Test: PR2.1.1)

Two single applications of rotigotine patches from two different manufacturing processes in the order B-A separated by a washout phase of at least 5 days

Group Type EXPERIMENTAL

Rotigotine transdermal patch

Intervention Type DRUG

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

Interventions

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Rotigotine transdermal patch

Rotigotine 4.5mg/10cm\^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