The effect of food on the pharmacokinetics of Ginsenoside C-K

• Register: ChiCTR
• Last refreshed on: 18 April 2017
• Main ID: ChiCTR-IPR-15005787
• Date of registration: 2015-01-06
• Prospective Registration: Yes
• Primary sponsor: Institute of Clinical Pharmacology, Central South University
• Public title: The effect of food on the pharmacokinetics of Ginsenoside C-K
• Scientific title: To study the effect of food on pharmacokinetics of Ginsenoside C-K tablet in healthy volunteers
• Date of first enrolment: 2015-01-15
• Target sample size: Two groups:24;
• Recruitment status: Pending
• URL: http://www.chictr.org.cn/showproj.aspx?proj=10212
• Study type: Interventional study
• Study design: Randomized parallel controlled trial
• Phase: I (Phase I study)

Countries of recruitment

China

Contacts

• Name: Yaqin Wang
• Affiliation: Central South University

• Name: DongSheng Ouyang

Key inclusion & exclusion criteria

Inclusion criteria: 1. Sex: male or female;
2. Age: 18~45 years old, the age difference in the same group is not more than 10 years; 3 weight: female weight greater than or equal to 45 kg, male weight greater than or equal to 50 kg, the body mass index (BMI) in 19~24 kg/m2 (BMI= body weight (kg)/height 2 (M2)), including the boundary value;
4. On the basis of a physical examination, medical history, vital signs, electrocardiogram and clinical laboratory test results, the researchers believe that the subjects in good health, heart, liver, kidney, gastrointestinal, neurological, psychiatric disorders and metabolic disorders and other medical history; the complete physical examination and vital signs, body temperature, heart rate and blood pressure check display, respiratory conditions and laboratory examination including ECG, chest X-ray, blood routine, urine routine, liver and kidney function, blood glucose, blood lipid, serum electrolytes, myocardial enzyme, blood coagulation function, blood transfusion, pregnancy (four women) the laboratory examination showed no abnormality or no clinical significance of abnormal (to the clinician's judgment shall prevail);
5. subjects must be informed consent before the trial, and voluntarily signed the written informed consent;
6. subjects can communicate with the researchers and be able to finish the study in accordance with the protocol.
Exclusion criteria: 1. allergic or known to this product or any of its accessories allergy;
2. circulating system, endocrine system, nervous system, digestive system, respiratory system, hematology, immunology, psychiatry and abnormal metabolism of any clinical history of serious illness or to interfere with the test results of any other disease or physical condition;
3. undergoing gastrointestinal problems, spasm, gastrointestinal ulcer, urinary infarction, intestinal obstruction, ureteral spasm, biliary tract disease, depression or liver disease;
4. with can affect drug absorption or metabolism of gastrointestinal and liver, kidney disease;
5. test within 4 weeks before treated with surgical operation;
6. known to affect the venous blood of serious hemorrhage factors;
7. with malignant tumor of history;
8. test 30 days before the use of any inhibition or induction of hepatic drug on drug metabolism (such as: inducing agent, barbiturates, phenytoin, C Masi Bing, glucocorticoid, Omeprazole; inhibitor SSRI antidepressants, cimetidine, diltiazem, macrolides, nitroimidazole, sedative hypnotics, Vera Pammy, fluoroquinolones, antihistamine) who; Abnormal ECG;
9. with clinical significance of vital signs) or abnormal (systolic blood pressure lower than 90 mmHg or higher than 140 mmHg, lower than 50 mmHg or higher than 90 mmHg diastolic blood pressure; heart rate less than 50 BPM or more than 100 BPM);
10. HIV, hepatitis B surface antigen, hepatitis or syphilis antibody positive;
11. alcoholic or 6 months before the test current drinkers, drinking more than 14 units of alcohol per week (1 units of =360 mL beer or 45 mL alcohol content of 40% spirits or 150 mL Wine);
12. smoker or test before 3 months of daily smoking more than 5 cigarettes;
13. drug abusers or test 3 months before the use of soft drugs (such as: marijuana) or test 1 years ago taking hard drugs (such as: cocaine, PCP etc.) who;
14. any food allergies or food to have special requirements, can not comply with the uniform diet;
15. every day drinking too much tea, Coffee and / or caffeinated beverages (more than 8 cups, 1 cup of =250 ml) who;
16. test 14 days before taking any drugs;
17. test in the 3 months before taking any drug clinical trials or in any drug clinical trials;
18. test 3 months before the blood donation or be sampled as the subjects';
19. subjects may be because of other reasons not to complete this study or research that should not be included in the party. Female subjects in addition to the above requirements, in accordance with the following conditions should also be excluded:
1) plan has been taken for 30 days before the test or tests during the taking oral contraceptives;
2) program has been using test within 6 months before or during the trial use of long-acting estrogen or progesterone injection or implantation of the piece;
3) women of childbearing age before the test within 14 days with a partner who has unprotected sexual intercourse;
4) during the screening period or in the menstrual cycle test;
5) during pregnancy and lactating women.

Age minimum: 18
Age maximum: 45
Gender: Both

Health Condition(s) or Problem(s) studied

rheumatoid arthritis

Intervention(s)

Two groups:Ginsenoside compound K is administrated after taking food versus fasting;

Primary Outcome(s)

Plasma, urine, concentration of ginsenoside C-K and its metabolites in feces of drugs;

Source(s) of Monetary Support

provided by enterprises