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

UCB Pharma40 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Healthy Volunteers

Interventions

rotigotine transdermal patch (Neupro®)DRUG

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

Eligibility

Sex: MALEMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Unnamed facility

Neuss, North Rhine-Westphalia, Germany

Outcomes

Primary Outcomes

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.