Clinical trial NCT02046031: Preliminary Study of Pharmacokinetics of Ginkgolides Meglumine Injection.
Official title: Preliminary Study of Pharmacokinetics of Ginkgolides Meglumine Injection.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Ischemic Stroke
Keywords: Ischemic stroke
safety
Pharmacokinetics
Ginkgolides Meglumine Injection
Lead sponsor: Jiangsu Kanion Pharmaceutical Co., Ltd
Sponsor class: INDUSTRY
Collaborators: name: Beijing Bionovo Medicine Development Co., Ltd.
First posted: 2014-01-27
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Maximum plasma concentration (Cmax)
timeFrame: 0, 4 days.
measure: Time to maximum plasma concentration (Tmax)
timeFrame: 0, 4 days.
measure: Area under the curve (AUC)
timeFrame: 0, 4 days.
measure: Elimination half-life (t1/2)
timeFrame: 0, 4 days.
measure: clearance (CL)
timeFrame: 0, 4 days.
measure: Volume of distribution (Vd)
timeFrame: 0, 4 days.
Secondary outcomes:
measure: Safety assessments will be based on adverse event reports and the results of vital sign measurements, electrocardiogram, Electrocardiogram monitoring and clinical laboratory tests.
timeFrame: 0, 4days
Other outcomes:
Locations:
city: Nanjing
country: China
facility: The first affiliated hospital with Nanjing Medical University
state: Jiangsu
Study officials:
affiliation: The First Affiliated Hospital with Nanjing Medical University
name: Ou Ning
role: PRINCIPAL_INVESTIGATOR
References: