A Study to Assess Pharmacokinetic Profiles of LY03003 and Neupro

Exclusion Criteria

• •1. History of symptomatic orthostatic hypotension with a decrease of ≥20 mmHg in systolic blood pressure (SBP) or decrease of ≥10 mmHg in diastolic blood pressure (DBP) when changing from a supine to a standing position after having been in the supine position for at least 5 minutes or SBP less than 105 mmHg in a supine position at screening;
• •2. Clinically significant history of gastrointestinal, cardiovascular, musculoskeletal, endocrine, hematologic, psychiatric, renal, hepatic, bronchopulmonary, neurologic, immunologic, and/or lipid metabolism disorders, and/or drug hypersensitivity;
• •3. History of epilepsy, seizures as an adult, lifetime history of stroke, or transient ischemic attack (TIA) within 1 year prior to screening;
• •4. History of sleep attacks or narcolepsy;
• •5. Known or suspected malignancy within 5 years with the exception of treated and cured basal cell carcinoma (skin), squamous cell carcinoma (skin), or in-situ cervical carcinoma;
• •6. Positive blood screen for human immunodeficiency virus (HIV) antibody, hepatitis B surface antigen (HBsAg), or hepatitis C antibody;
• •7. Positive pregnancy test result or plan to become pregnant if female;
• •8. Female who is pregnant or breastfeeding or of childbearing potential without adequate contraception (see Inclusion Criterion 7);
• •9. Hospital admission or major surgery within 30 days prior to screening;
• •10. Receipt of another investigational product within one month or 5 half-lives of the other investigational product, whichever is longer, before study drug administration in this study.
• •11. History of prescription drug abuse or any illicit drug use within 6 months prior to screening;
• •12. History of alcohol abuse according to medical history within 6 months prior to screening;
• •13. Positive screen for alcohol or drugs of abuse;
• •14. Unwillingness or inability to comply with food and beverage restrictions during study participation;
• •15. Donation or blood collection of more than 1 unit (approximate 450 mL) of blood (or blood products) or acute loss of blood during the 90 days prior to screening;
• •16. Use of prescription or over-the-counter (OTC) medications and/or herbal supplements (including St John's Wort, herbal teas, garlic extracts) within 14 days prior to dosing (Note: Use of acetaminophen at \<3 g/day is permitted until 24 hours prior to dosing);
• •17. Inability to tolerate study drug in any prior rotigotine or LY03003 trial or intolerance or hypersensitivity to rotigotine or any excipients or diluents (Poly (lactide-co-glycolide) \[PLGA\], carboxymethylcellulose sodium \[SCMC\], stearic acid, or mannitol);
• •18. History of known intolerance/hypersensitivity to antiemetics such as ondansetron, tropisetron, and glycopyrrolate;
• •19. History of suicide attempt in the past 6 months and/or seen by the investigator as having a significant history of risk of suicide or homicide;