Pilot BA Study of New LY03005 vs Pristiq

Exclusion Criteria

• •1. Clinically significant past history of gastrointestinal, cardiovascular, musculoskeletal, endocrine, hematologic, psychiatric, renal, hepatic, bronchopulmonary, neurologic, immunologic, lipid metabolism disorders, ophthalmological, or drug hypersensitivity;
• •2. History of suicide attempt in the past 12 months and/or seen by the investigators having a significant history of risk of suicide or homicide;
• •3. History or presence of malignancy other than adequately treated basal cell skin cancer;
• •4. Clinically relevant illness within one month prior to the screening visit or at screening visit that may interfere with the conduct of this study;
• •5. Subjects with a mean systolic blood pressure of three measurements \>140 mmHg, or a mean diastolic blood pressure of three measurements \>90 mmHg at screening;
• •6. Positive blood screen for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C antibody;
• •7. A history of seizure. However, a history of febrile seizure is allowed;
• •8. A hospital admission or major surgery within 30 days prior to screening;
• •9. Participation in any other investigational drug trial within 30 days prior to screening;
• •10. A history of prescription drug abuse, or illicit drug use within 6 months prior to screening;
• •11. A history of alcohol abuse according to medical history within 6 months prior to screening;
• •12. A positive screen for alcohol, drugs of abuse;
• •13. Tobacco use within 6 months prior to screening based on subject report;
• •14. Subjects with hypersensitivity to PRISTIQ or medicines containing desvenlafaxine or its precursor venlafaxine;
• •15. Subjects who have participated in a previous clinical study of either LY03005 or PRISTIQ or medicines containing desvenlafaxine or its precursor, venlafaxine within 30 days prior to screening;
• •16. An unwillingness or inability to comply with food and beverage restrictions during study participation;
• •17. 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;
• •18. Use of prescription or over-the-counter (OTC) medications, and herbal (including St John's Wort, herbal teas, garlic extracts) within 14 days prior to dosing (Note: Use of acetaminophen at \< 3g/day is permitted until 24 hours prior to dosing).