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

Trial end date:
Target enrollment:
Participant gender:
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.
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Lead Sponsor:
UCB Pharma
Otsuka Pharmaceutical Co., Ltd.
N 0437
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