Preliminary Study of Pharmacokinetics of Ginkgolides Meglumine Injection.

Ischemic Stroke Clinical Trial

Official title:

Preliminary Study of Pharmacokinetics of Ginkgolides Meglumine Injection.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02046031
• Other study ID #: Z-YXPU-ZS-IV3
• Status: Completed
• Phase: Phase 4
• First received: January 19, 2014
• Last updated: July 13, 2014
• Start date: February 2014
• Est. completion date: June 2014

Study information

• Verified date: December 2013
• Source: Jiangsu Kanion Pharmaceutical Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 40 Years

Eligibility

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.

Study Design

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ischemic Stroke

Intervention

Drug:
• Ginkgolides Meglumine Injection
25 mg, ivdrip, once.

Locations

Country	Name	City	State
China	The first affiliated hospital with Nanjing Medical University	Nanjing	Jiangsu

Sponsors (2)

Lead Sponsor	Collaborator
Jiangsu Kanion Pharmaceutical Co., Ltd	Beijing Bionovo Medicine Development Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	0, 4 days.	No
Primary	Time to maximum plasma concentration (Tmax)	Biological sample including blood, urine, faeces for PK will be collected at the same time point.	0, 4 days.	No
Primary	Area under the curve (AUC)	Biological sample including blood, urine, faeces for PK will be collected at the same time point.	0, 4 days.	No
Primary	Elimination half-life (t1/2)	Biological sample including blood, urine, faeces for PK will be collected at the same time point.	0, 4 days.	No
Primary	clearance (CL)	Biological sample including blood, urine, faeces for PK will be collected at the same time point.	0, 4 days.	No
Primary	Volume of distribution (Vd)	Biological sample including blood, urine, faeces for PK will be collected at the same time point.	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.	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.	0, 4days	Yes