Preliminary Study of Pharmacokinetics of Ginkgolides Meglumine Injection.


Phase 4 Results N/A

Eligibility Criteria

Inclusion Criteria

- Ages 18-40, no more than 10 years apart.
- Both male and female.
- Subjects have standard weight( generally not less than 50 kg), and body mass index (BMI) within 19-25. Subjects weight (kg) should not differ too much.
- All physical examinations( including ECG, kidney function, liver function
, blood routine, urine routines, etc) are normal.
- History of disease: no history of diseases in gastrointestinal tract, reproductive tract, urinary tract, heart, liver, kidney, lung, nervous system, metabolism, and no history of allergies and orthostatic hypotension.
- After being told all possible adverse reactions associated with the drug, subjects sign the informed consent and promise to complete all examinations.

Exclusion Criteria

- Subjects who cannot communicate with medical staff, and subjects with cerebral insufficiency or psychological problem.
- Female subjects or partner of male subjects have plan to pregnant.
- Subjects have primary disease in significant organ.
- Subjects have history of drug dependence or psychosis in last 2 years.
- Subjects have blood loss or blood donation more than 200 mL 3 months prior to the baseline.
- Subjects who have taken part in other clinical trials 3 months prior to the baseline.
- Subjects who abuse alcohol or other drugs.
- Pregnancy or breast-feeding subjects.
- Subjects is found to have clinical significance of abnormal after checking information and physical examinations.
- Known allergies or serious side effects with no more than two kinds of food and drugs in the past.
- Subjects who have taken any drug during the previous 2 weeks.
- Subjects have unexplained infections.
- The subjects could not complete the study in the opinion of the Principal Investigator due to any reason.
- Positive HIV、HCV and HBsAg test results.
- A female subject whose pregnancy test is positive.