Pharmacokinetics of human body
Conditions
Interventions
Group 1:Ginkgolide Dropping Pills, qd
Group 2:Ginkgolide Dropping Pills, bid
Group 3:Ginkgolide Meglumine Injection, qd
Sponsors
First Teching Hospital of Tijianjin University of TCM
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subjects 18 to 45 years old (half male and female); 2. BMI = body weight =50 kg and body mass index (BMI) = 19-26 kg / m2 (including 19 kg / m2 and 26 kg / m2) [BMI = body weight (kg) / height 2 (m2)]; 3. According to the past medical history, physical examination and laboratory tests to prove the subject's health; 4. Good communication with researchers and compliance with the requirements of the entire study; 5. Before the experiment, the nature, significance, possible benefits, possible inconveniences and potential dangers of the test have been fully understood and volunteered to participate in the clinical trial, understand the research procedure and sign the written informed consent form.
Exclusion criteria
Exclusion criteria: 1. Known to be allergic to test drug components or analogues, or have other drugs, food allergy history; 2. Participate in this clinical trial within 3 months before participating in other clinical trials; 3. Have donated blood within 3 months prior to participating in this clinical trial, or plan to donate blood within 3 months of the trial or after the trial, or have transfused within 4 weeks prior to the trial; 4. to participate in this clinical trial within 2 weeks before taking drugs; 5. Previous alcoholism (ie men drink more than 28 standard units weekly, women drink more than 21 standard units weekly (1 standard unit contains 14g of alcohol, such as 360mL of beer or 45mL of 40% spirits or 150mL of wine), Or regular drinking within 6 months prior to trial screening (more than 14 standard drinks per week); 6. Investigate positive drug tests prior to first administration or have a history of drug abuse (eg, morphine, marijuana, etc.) within 1 year prior to the test; 7. Heart, liver, kidney, digestive tract, nervous system, mental disorders and metabolic disorders and other medical history; 8. Pregnant or lactating women, as well as male subjects (or their partners) or female subjects who have a pregnancy plan within 2 months of their administration and within 3 months of the end of their study, are reluctant to take appropriate contraception; 9. The vital signs, physical examination, electrocardiogram and laboratory test results abnormalities, the researchers judged not to participate in the test; 10. Bleeding with bleeding or bleeding tendency who have venous thrombosis were disabled; 11. Known HIV, HBV, HCV virus and Treponema pallidum infection; 12. Researchers believe there are other volunteers who should not participate in this trial; 13. Researchers themselves and their family members.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Ginkgolide A open-loop total concentration and open-loop concentration of the concentration;Ginkgolide B open-loop total concentration and open-loop concentration of the concentration;Ginkgolide K open-loop total concentration and open-loop concentration of the concentration; | — |
Countries
China
Contacts
Public ContactHu Siyuan
The First Affiliated Hospital of Tijianjin University of Traditional Chinese Medcine
Outcome results
None listed