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Preliminary Study of Pharmacokinetics of Ginkgolides Meglumine Injection.

Primary Purpose

Ischemic Stroke

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Ginkgolides Meglumine Injection
Sponsored by
Jiangsu Kanion Pharmaceutical Co., Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ischemic Stroke focused on measuring Ischemic stroke, safety, Pharmacokinetics, Ginkgolides Meglumine Injection

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • The first affiliated hospital with Nanjing Medical University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Ginkgolides Meglumine Injection

Arm 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.

Outcomes

Primary Outcome Measures

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 to maximum plasma concentration (Tmax)
Biological sample including blood, urine, faeces for PK will be collected at the same time point.
Area under the curve (AUC)
Biological sample including blood, urine, faeces for PK will be collected at the same time point.
Elimination half-life (t1/2)
Biological sample including blood, urine, faeces for PK will be collected at the same time point.
clearance (CL)
Biological sample including blood, urine, faeces for PK will be collected at the same time point.
Volume of distribution (Vd)
Biological sample including blood, urine, faeces for PK will be collected at the same time point.

Secondary Outcome Measures

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.

Full Information

First Posted
January 19, 2014
Last Updated
July 13, 2014
Sponsor
Jiangsu Kanion Pharmaceutical Co., Ltd
Collaborators
Beijing Bionovo Medicine Development Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT02046031
Brief Title
Preliminary Study of Pharmacokinetics of Ginkgolides Meglumine Injection.
Official Title
Preliminary Study of Pharmacokinetics of Ginkgolides Meglumine Injection.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
February 2014 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
June 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jiangsu Kanion Pharmaceutical Co., Ltd
Collaborators
Beijing Bionovo Medicine Development Co., Ltd.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Stroke
Keywords
Ischemic stroke, safety, Pharmacokinetics, Ginkgolides Meglumine Injection

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
4 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ginkgolides Meglumine Injection
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Ginkgolides Meglumine Injection
Intervention Description
25 mg, ivdrip, once.
Primary Outcome Measure Information:
Title
Maximum plasma concentration (Cmax)
Description
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.
Title
Time to maximum plasma concentration (Tmax)
Description
Biological sample including blood, urine, faeces for PK will be collected at the same time point.
Time Frame
0, 4 days.
Title
Area under the curve (AUC)
Description
Biological sample including blood, urine, faeces for PK will be collected at the same time point.
Time Frame
0, 4 days.
Title
Elimination half-life (t1/2)
Description
Biological sample including blood, urine, faeces for PK will be collected at the same time point.
Time Frame
0, 4 days.
Title
clearance (CL)
Description
Biological sample including blood, urine, faeces for PK will be collected at the same time point.
Time Frame
0, 4 days.
Title
Volume of distribution (Vd)
Description
Biological sample including blood, urine, faeces for PK will be collected at the same time point.
Time Frame
0, 4 days.
Secondary Outcome Measure Information:
Title
Safety assessments will be based on adverse event reports and the results of vital sign measurements, electrocardiogram, Electrocardiogram monitoring and clinical laboratory tests.
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ou Ning
Organizational Affiliation
The First Affiliated Hospital with Nanjing Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The first affiliated hospital with Nanjing Medical University
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
201129
Country
China

12. IPD Sharing Statement

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Preliminary Study of Pharmacokinetics of Ginkgolides Meglumine Injection.

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