Study in Healthy Volunteers to Prove That 2 Rotigotine Patches From Different Manufacturing Processes Deliver Equivalent Drug Amount to the Body.

UCB Pharma52 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 processes.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

Rotigotine transdermal patchDRUG

Rotigotine 4.5mg/10cm\^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.

Time frame: 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.

Time frame: 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 Outcomes

AUC(0-∞) of Unconjugated Rotigotine

The AUC(0-∞) is the area under the plasma concentration- time curve from zero up to infinity.

Time frame: 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 (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).

Time frame: 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).

Time frame: 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.

Data from ClinicalTrials.gov

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