inflammation
Conditions
Interventions
1:Ginsenoside Compound K solubilizing tablet(50mg/ tablet, 25 mg/ tablet) and Ginsenoside Compound K tablet (50mg/ tablet)
Sponsors
Institute of Clinical Pharmacology, Central South University
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1)Healthy volunteers, aged 18 to 45 years, same batch age difference is not more than 10 years old;2) Weighing more than 40 kg, subjects body mass index (BMI) between 19 ~ 24 kg/m2, including the boundary values, the same batch of the weight difference should not be disparity;3) Healthy female volunteers must not be pregnant women or lactation period,and have no plan to be pregnant in 6 months;4) Subjects voluntarily participate in the trial and willing to be tested in accordance with the test procedures prescribed;5) Subjects can have an good communication with researchers and finish this research according to our stipulation.
Exclusion criteria
Exclusion criteria: 1)four weeks before the test suffered from clinically significant disease or accepted surgery; 2)be highly allergic to this drug; 3)have a history of any clinical history of serious illness or cardiovascular system, endocrine system, nervous system disease or lung, hematology, immunology, psychiatry diseases and metabolic abnormalities; 4)have a history of gastrointestinal disease or kidney diseases,and are uncomfortable in digestive tract; 5)have hepatic encephalopathy,serious hepatic failure or kidney failure; 6)the results of any laboratory tests in one week the presence of clinically significant abnormal situation; 7)electrocardiogram or vital signs are abnormal before or between the test(systolic blood pressure140 mmHg;diastolic pressure 90 mmHg;heart rate 100 bpm ); 8)have drug or ethanol abuse history within one year; 9)have taken drugs inhibiting or inducing liver to metabolize drugs(inductive agent:Barbitals,Carbamazepine,Phenytoin;inhibitor:Cimetidine,nitro imidazoles) 10)to participate in the trial within 14 days of concomitant medication; 11)within one months to participate in other drug trials; 12)within 3 months before the test in blood donors;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| relative bioavailability;pharmacokinetics parameter; | — |
Contacts
Public ContactDongSheng Ouyang
Institute of Clinical Pharmacology, Central South University
Outcome results
None listed