Bioavailability of 5 mg of Levamlodipine Maleate Tablets Versus 10 mg of Amlodipine Besylate Tablet in Healthy Subjects

Exclusion Criteria

• •1. Clinically significant history of gastrointestinal, cardiovascular, musculoskeletal, endocrine, hematologic, psychiatric, renal, hepatic, bronchopulmonary, neurologic, immunologic, lipid metabolism disorders, or drug hypersensitivity;
• •2. Mean systolic blood pressure of three measurements \>140 mmHg, or a mean diastolic blood pressure of three measurements \>90 mmHg at screening.
• •3. Known or suspected malignancy;
• •4. Positive blood screen for human immunodeficiency virus (HIV), or hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV);
• •5. A history of seizure. However, a history of febrile seizure is allowed;
• •6. Positive pregnancy test result, or plan to become pregnant if female;
• •7. A hospital admission or major surgery within 30 days prior to screening;
• •8. Participation in any other investigational drug trial within 30 days prior to screening;
• •9. DSM-V substance use disorder within 6 months prior to screening;
• •10. A positive result for alcohol or drugs of abuse at screening or admission;
• •11. Tobacco use within 6 months prior to screening;
• •12. An unwillingness or inability to comply with food and beverage restrictions during study participation;
• •13. 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;
• •14. Use of prescription or over-the-counter (OTC) medications, and herbal medicines (including St John's Wort, herbal teas, garlic extracts) within 14 days prior to dosing;
• •15. A history of suicide attempt in the past 12 months and/or seen by the investigator as having a significant history of risk of suicide or homicide;
• •16. A history of intolerance or hypersensitivity to amlodipine or any excipients;
• •17. An unwillingness of male participants to use appropriate contraceptive measures if engaging in sex intercourse with a female partner of childbearing potential during the study and 60 days after discontinuation of study treatment.