A Phase 4 interventional study of Ginkgolides Meglumine Injection in Ischemic Stroke, sponsored by Jiangsu Kanion Pharmaceutical Co., Ltd. Completed at 1 site in China. Open to participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-07-15.
Sponsored by Jiangsu Kanion Pharmaceutical Co., Ltd · Phase 4, Interventional, and Treatment
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.
2,593 studies on the registry are indexed under Ischemic Stroke; 930 are open to participants now.
This study's enrollment of 4 is below the median of 120 across 1,752 interventional studies indexed under Ischemic Stroke.
Browse Ischemic Stroke studies →Jiangsu Kanion Pharmaceutical Co., Ltd is the lead sponsor of 12 studies on the registry; 2 are open to participants now.
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All physical examinations( including ECG, kidney function, liver function
, blood routine, urine routines, etc) are normal.
Exclusion Criteria:
Intravenous drip slowly. A 1 (25 mg), will be taken slowly into the 0.9% sodium chloride injection diluted in 250 ml before use, then slow intravenous drip, once a day. The dripping speed must be strictly controlled. For the first time when using Ginkgolides Meglumine Injection, dripping speed should be controlled for 10 \~ 15 drops per minute. After 30 minutes treatment without discomfort, dripping speed can be appropriately increased, but no more than 30 drops per minute.
Drug: Ginkgolides Meglumine Injection
25 mg, ivdrip, once.
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.
Time frame: 0, 4days
This study is completed, as verified in Dec 2013. You cannot join it, but the record below documents what was studied.
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Jiangsu Kanion Pharmaceutical Co., Ltd