Study in Healthy Volunteers to Prove That Two Different Formulations of Rotigotine Patches Deliver Equivalent Drug Amount to the Body

UCB

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: Rotigotine transdermal patch

Study type: Interventional

Funder types: Industry

Identifiers

NCT01059903

SP0987

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 two Rotigotine patches of two different formulations

Enrollment: 50 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/m^2 (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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

50 participants in 2 patient groups

Rotigotine PR2.2.1 first

Experimental group

Description:

Rotigotine transdermal patch 4.5 mg/10 cm\^2, test drug product PR2.2.1 followed by Rotigotine transdermal patch 4.5 mg/10 cm\^2, reference drug product PR2.1.1 separated by a washout phase of at least 5 days

Treatment:

Drug: Rotigotine transdermal patch

Rotigotine PR2.1.1 first

Experimental group

Description:

Rotigotine transdermal patch 4.5 mg/10 cm\^2, reference drug product PR2.1.1 followed by Rotigotine transdermal patch 4.5 mg/10 cm\^2, test drug product PR2.2.1 separated by a washout phase of at least 5 days

Treatment:

Drug: Rotigotine transdermal patch