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

UCB

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: rotigotine transdermal patch (Neupro®)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00957944

SP0957

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Sequence A-B (Test: PR 2.1.1 WCL - Reference: PR 2.1.1 AND)

Experimental group

Description:

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

Treatment:

Drug: rotigotine transdermal patch (Neupro®)

Sequence B-A (Reference: PR 2.1.1 AND - Test: PR 2.1.1 WCL)

Experimental group

Description:

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

Treatment:

Drug: rotigotine transdermal patch (Neupro®)