To explore the rule of absorption, distribution, metabolism and elimination after intravenous administration of Ginkgolides Meglumine Injection healthy subjects. The plasma drug profiles will be important to assess the potential clinical drug-drug interactions.
Ginkgolides Meglumine Injection was jointly developed by China Pharmaceutical University and Jiangsu Kanion Pharmaceutical Co., Ltd. Its pharmacal ingredients are ginkgo lactones A , ginkgo lactone B, ginkgo lactone K, etc; Excipients for meglumine, citric acid, sodium chloride. It is used to treat stroke (mild-to-moderate cerebral infarction) in recovery phlegm and Syndrome of Intermingled Phlegm and Blood Stasis. The aim of this study is to explore the rule of absorption, distribution, metabolism and elimination after intravenous administration of Ginkgolides Meglumine Injection healthy subjects. The plasma drug profiles will be important to assess the potential clinical drug-drug interactions. Biological sample including blood and urine for PK is collected during the study. In the first stage, the biological sample of two subjects will be collected at different time points. In the second stage, the biological sample of another two subjects will be collected at the time points which are adjusted according to the results of the first stage.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
4
25 mg, ivdrip, once.
The first affiliated hospital with Nanjing Medical University
Nanjing, Jiangsu, China
Maximum plasma concentration (Cmax)
Blood will be drawn from adult subjects pre-drug application and at 30min, 60min, 90min, 150min, 197min, 205min, 215min, 240min (4h), 300min(5h), 360min (6h), 480min (8h), 720min (12h),1440min(24h),2160min(36h), 2880min (48h), 4320min (72h). Urine will be drawn from adult subjects pre-drug application and at 0-4, 4-6, 6-12, 12-24, 24-48, 48-72.
Time frame: 0, 4 days.
Time to maximum plasma concentration (Tmax)
Biological sample including blood, urine, faeces for PK will be collected at the same time point.
Time frame: 0, 4 days.
Area under the curve (AUC)
Biological sample including blood, urine, faeces for PK will be collected at the same time point.
Time frame: 0, 4 days.
Elimination half-life (t1/2)
Biological sample including blood, urine, faeces for PK will be collected at the same time point.
Time frame: 0, 4 days.
clearance (CL)
Biological sample including blood, urine, faeces for PK will be collected at the same time point.
Time frame: 0, 4 days.
Volume of distribution (Vd)
Biological sample including blood, urine, faeces for PK will be collected at the same time point.
Time frame: 0, 4 days.
Safety assessments will be based on adverse event reports and the results of vital sign measurements, electrocardiogram, Electrocardiogram monitoring and clinical laboratory tests.
Adverse event reports will be assessed at 0, 4 days. Vital sign measurements will be assessed at pre-drug application and 30min, 60mi, 120min, 197min, 4h, 12h, 24h, 48h, 72h after application. Electrocardiogram will be assessed at 0, 4 days. Electrocardiogram monitoring will be assessed during medication period. Clinical laboratory tests will be assessed at 0, 4 days.
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Time frame: 0, 4days