Pharmacokinetics and Pharmacodynamics of Higenamine in Chinese Healthy Subjects
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Layout table for eligibility information
Ages Eligible for Study:
19 Years to 45 Years (Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Subjects must meet all the following inclusion criteria to be eligible to participate in this study:
Chinese healthy adult males, female subjects (either gender the proportion of not less than 1 / 3).
Age: 19 to 45 (including 19, 45) years old.
Male body weight ≥ 50kg, female body weight ≥ 45kg, and body mass index within the normal range (weight (kg) / height 2 (m2) = 18-25).
Informed consent form is obtained.
Subjects will be excluded from entry if any of the criteria listed below are met:
Presence or history of any disorder of cardiovascular system, respiratory system, digestive system, urogenital system, endocrine system, allergy / immune system, blood system, nervous / mental system, musculoskeletal system, skin diseases.
History of any drug hypersensitivity.
Female urine pregnancy test was positive.
Positive serologic findings for human immunodeficiency virus (HIV) antibodies, hepatitis B surface antigen (HBsAg), hepatitis B e antigen (HBeAg), and/or hepatitis C virus (HCV) antibodies.
Acute disease state or infection associated with prescription drugs within 1 month before study day 1.
Taking any drugs, including over-the-counter drugs and herbal supplements within 7 days before study day 1.
History of alcohol abuse (consuming greater than 14 glasses of alcoholic beverages each week, 1 glass is approximately equivalent to: beer 284 mL, wine 125 mL, or distilled spirits [25 mL).
History of drug abuse.
Smoker or subjects quitting smoking less than 1 month before study day 1.
Participating other trials within 1 month before study day 1.
Donating blood (> 400 mL) within 1 month before study day 1.
During screening, alcohol breath test result > 0.000.