trial to evaluate the pharmacokinetics, safety, and tolerability of rotigotine in healthy korean subjects

Conditions: Parkinson's Disease

Summary: the objective of this trial is to investigate the pk (pharmacokinetic) of repeated-dose applications of the rotigotine transdermal patch in healthy young male and female korean subjects to be submitted to mfds for new drug application approval.


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

Keywords: parkinson's disease rotigotine pharmacokinetics healthy subjects