Clinical trial NCT01964573 (phase 1, status: completed)
Conditions: parkinson's disease
ICD codes: G20
Drugs: rotigotine
SMILES: CCCN(CCC1=CC=CS1)[C@H]1CCC2=C(O)C=CC=C2C1
Eligibility criteria:

        Inclusion Criteria:

          -  Subject is male or female and aged between 19 and 45 years of age (inclusive)

          -  Subject is healthy (no clinically relevant findings in any of the investigations of
             the pre-examination) as judged by the investigator

          -  Subject is of normal body weight as determined by a Body Mass Index (BMI) between 18
             and 28 kg / m²

          -  Subject is Korean (both parents are pure Korean)

        Exclusion Criteria:

          -  Subject has had a history of drug or alcohol abuse within the last 2 years

          -  Subject has had a history of transient ischemic attack or stroke within the last 12
             months

          -  Subject has a history or current condition of Epilepsy and / or seizures

          -  Subject has a history of significant skin hypersensitivity to adhesives or other
             transdermal products or recently unsolved Contact Dermatitis

          -  Subject has a history or present condition of an Atopic or Eczematous Dermatitis,
             Psoriasis, and / or an active skin disease

          -  Female subject is pregnant or lactating

          -  Subject has any medical or psychiatric condition that, in the opinion of the
             investigator, could jeopardize or would compromise the subject's ability to
             participate in this trial

          -  Subject has a QTcB (according to Bazett´s formula) interval of ≥ 450 ms for female or
             ≥ 430 ms for male or any other clinically relevant Electrocardiogram (ECG) finding

          -  Subject has any clinically relevant abnormality in the physical examination, or any
             clinically relevant deviation from the normal range in the clinical chemistry,
             hematology, or urinalysis

          -  Subject has a relevant hepatic dysfunction (total Bilirubin > 2 mg /dL or Alanine
             Aminotransferase [ALT] or Aspartate Aminotransferase [AST] greater than 2 times the
             upper limit of the normal reference range)

          -  Subject has a positive test for Human Immunodeficiency Virus antibodies (HIV)-1/2Ab,
             Hepatitis B surface Antigen (HBsAg) or Hepatitis C Virus Antibody (HCV-Ab)

          -  Subject has a positive test for alcohol or drugs

          -  Subject consumes more than 150 g of alcohol / week

          -  Subject has made a blood donation or had a comparable blood loss (> 400 ml) within the
             last 3 months

          -  Subject smokes more than 5 cigarettes per day or has done so within previous 6 months

          -  Subject has a clinically relevant allergy

          -  Subject is taking any medication (excluding oral hormonal contraceptive) currently or
             within 2 weeks prior to the first day of dosing (with the exception of Acetaminophen
             [up to 1000 mg per day per os] which may have been taken up to 48 hours prior to
             commencement of dosing)

          -  Female subject is currently taking an oral hormonal contraceptive but less than 2
             months

          -  Subject has a symptomatic orthostatic hypotension with a decrease of Blood Pressure
             (BP) from supine to standing position of ≥ 20 mmHg in systolic BP or of ≥ 10 mmHg in
             diastolic BP after 1 and / or 3 minutes

          -  Subject has a pulse rate at rest less than 45 beats per minute or more than 100 beats
             per minute (measured in supine position)

          -  Subject has a systolic Blood Pressure (BP) lower than 100 mmHg or higher than 150 mmHg
             or diastolic BP higher than 95 mmHg (measured in supine position)

          -  Subject has a current or a history of clinically relevant motor disturbance,
             impairment of memory, sleep disturbance or neurodegenerative disease (e.g. , Alzheimer
             Dementia, Diffuse, Lewy Body Dementia, Amyotrophic Lateral Sclerosis [ALS], Multiple
             Sclerosis)

          -  Subject has taken herbal medicine therapy within the last 2 weeks

          -  Subject consumes more than 3 cups (more than 450 ml) of caffeinated beverages per day
             within the last 2 weeks