Bioequivalence Study of Rotigotine Transdermal Patch With Two Different Formulations in Healthy Japanese Subjects

UCB

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: Rotigotine PR 2.2.1; Drug: Rotigotine PR 2.1.4

Study type: Interventional

Funder types: Industry

Identifiers

NCT01565018

PD0002

2011-004851-38 (EudraCT Number)

Details and patient eligibility

About

To investigate and compare the drug amount delivered to the body after each single administration of Rotigotine patch with 2 different formulations in healthy Japanese subjects.

Enrollment: 55 patients

Sex: All

Ages: 20 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy Japanese male and female volunteers with the age between 20 and 55 years old

Exclusion criteria

• Subject has participated or is participating in any other clinical studies of investigational drug or another Investigational Medical Product (IMP) within the last 3 months
• Subject is not healthy (eg, taking any drug treatments, excessive amount of alcohol, cigarettes, having any medical or emotional/psychological problems, a drug/alcohol abuse, having abnormal safety parameters)
• Subject has a QTcB (QT interval corrected for Heart Rate [HR] using Bazett´s formula) interval of ≥ 430 ms (≥ 450 ms for females) or any other clinically relevant finding in Electrocardiogram (ECG) at the Eligibility Assessment (EA)
• Subject is having clinically relevant allergy or clinically relevant drug hypersensitivity to any components of the Investigational Medical Product (IMP), or/and having an atopic or eczematous Dermatitis, Psoriasis and/or active skin disease
• Subject has a recent history (within 2 years) of chronic alcohol or drug abuse and has a history of significant skin hypersensitivity to transdermal products, and of an atopic or eczematous Dermatitis, Psoriasis, and/or active skin disease and have a history of suicide attempt, Epilepsy and/or seizures
• Subject has made a blood donation or a comparable blood loss within the last 3 months prior to the Eligibility Assessment (EA)
• Subject is pregnant or nursing

Trial design

55 participants in 2 patient groups

Treatment A - Treatment B

Experimental group

Description:

Treatment A: Test; drug product PR 2.2.1 Treatment B: Reference; drug product PR 2.1.4 Sequence of two single applications of Rotigotine transdermal patches (PR 2.2.1 first) for 24 hours separated by a Washout Period of 5 days.

Treatment:

Drug: Rotigotine PR 2.1.4

Drug: Rotigotine PR 2.2.1

Treatment B - Treatment A

Experimental group

Description:

Treatment B: Reference; drug product PR 2.1.4 Treatment A: Test; drug product PR 2.2.1 Sequence of two single applications of Rotigotine transdermal patches (PR 2.1.4 first) for 24 hours separated by a Washout Period of 5 days.

Treatment:

Drug: Rotigotine PR 2.1.4

Drug: Rotigotine PR 2.2.1