Preliminary Study of Pharmacokinetics of Ginkgolides Meglumine Injection.

Completed

Phase 4 Results N/A

Trial Description

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.

Detailed Description

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.

Conditions

Interventions

  • Ginkgolides Meglumine Injection Drug
    Intervention Desc: 25 mg, ivdrip, once.
    ARM 1: Kind: Experimental
    Label: Ginkgolides Meglumine Injection
    Description: 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.

Trial Design

  • Masking: Open Label
  • Purpose: Treatment
  • Endpoint: Pharmacokinetics Study
  • Intervention: Single Group Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Maximum plasma concentration (Cmax) 0, 4 days. No
Primary Time to maximum plasma concentration (Tmax) 0, 4 days. No
Primary Area under the curve (AUC) 0, 4 days. No
Primary Elimination half-life (t1/2) 0, 4 days. No
Primary clearance (CL) 0, 4 days. No
Primary Volume of distribution (Vd) 0, 4 days. No
Secondary Safety assessments will be based on adverse event reports and the results of vital sign measurements, electrocardiogram, Electrocardiogram monitoring and clinical laboratory tests. 0, 4days Yes

Sponsors