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Preliminary Study of Pharmacokinetics of Ginkgolides Meglumine Injection.
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.
Details
| Lead sponsor | Jiangsu Kanion Pharmaceutical Co., Ltd |
|---|---|
| Phase | Phase 4 |
| Status | COMPLETED |
| Enrolment | 4 |
| Start date | 2014-02 |
| Completion | 2014-06 |
Conditions
- Ischemic Stroke
Interventions
- Ginkgolides Meglumine Injection
Primary outcomes
- Maximum plasma concentration (Cmax) — 0, 4 days.
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 to maximum plasma concentration (Tmax) — 0, 4 days.
Biological sample including blood, urine, faeces for PK will be collected at the same time point. - Area under the curve (AUC) — 0, 4 days.
Biological sample including blood, urine, faeces for PK will be collected at the same time point. - Elimination half-life (t1/2) — 0, 4 days.
Biological sample including blood, urine, faeces for PK will be collected at the same time point. - clearance (CL) — 0, 4 days.
Biological sample including blood, urine, faeces for PK will be collected at the same time point. - Volume of distribution (Vd) — 0, 4 days.
Biological sample including blood, urine, faeces for PK will be collected at the same time point.
Countries
China