Careseng 1370 for Healthy Volunteers

Exclusion Criteria

• •1. Volunteer who has a history or evidence of a medical condition that would expose them to a risk of a significant adverse event or interfere with the assessments of safety or pharmacodynamics variables during the course of the trial, including but not limited to hepatic, renal, respiratory, cardiovascular, endocrine, immune, neurological, musculoskeletal or hematological disease as determined by the clinical judgment of the investigator
• •2. Volunteer has received any other investigational agent within 28 days prior to the first dose of study drug
• •3. Volunteer has taken or potentially takes any herbal medication/supplements/medicinal food, prescription medication and/or over-the-counter medication within 2 weeks prior to the first dose of study drug
• •4. Volunteer has alcohol, caffeine, grapefruit juice, or nicotine consumption within 24 hours prior to the first dose of study drug
• •5. Female volunteer of childbearing potential who:
• •* is lactating; or
• •* has positive pregnancy test result at eligibility checking; or
• •* refuses to adopt at least two forms of birth control (at least one of which must be a barrier method) from Screening visit to Final visit.
• •Note:
• •Acceptable forms include:
• •1. Established use of oral, injected or implanted hormonal methods of contraception.
• •2. Placement of an intrauterine device (IUD) or intrauterine system (IUS).
• •3. Barrier methods of contraception: Condom OR Occlusive cap (diaphragm or cervical/vault caps)
• •6. Male volunteer with female spouse/partners who are of childbearing potential refuses to adopt at least two forms of birth control (at least one of which must be a barrier method) from Screening visit until Final visit
• •7. Known or suspected allergy or hypersensitivity to any ingredients of study product
• •8. With history of stroke, myocardial infarction, or Coronary Artery Bypass Graft (CABG) surgery within the last 6 months prior to the screening visit
• •9. With history of cardiac failure (NYHA class 2 or above), unstable angina, or life-threatening arrhythmia within the last 6 months prior to the screening visit Note: NYHA = New York Heart Association
• •10. With blood pressures as systolic blood pressure \< 90 mmHg or \> 170 mmHg or diastolic blood pressure \< 50 mmHg or \> 120 mmHg at eligibility checking
• •11. History of psychiatric disorder
• •12. History of left ventricular outflow obstruction, such as aortic stenosis and hypertrophic cardiomyopathy
• •13. With a history of human immunodeficiency virus (HIV) infection or hepatitis B or C infection
• •14. Plan to receive surgery from Screening visit until Final visit
• •15. Known or suspected hypersensitivity to any component of Careseng 1370, including components in plants of genus Panax, Tween 80, Kolliphor® P188, Fujicalin, and ginseng flavor