Preliminary Study of Pharmacokinetics of Ginkgolides Meglumine Injection.

NCT02046031 | Completed Phase 4

• 1 other identifier: Z-YXPU-ZS-IV3
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Ischemic Stroke

Keywords

Ischemic stroke; safety; Pharmacokinetics; Ginkgolides Meglumine Injection

Outcome Measures

Primary Outcomes (6)

• 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.

• 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.

• Area under the curve (AUC)

  Biological sample including blood, urine, faeces for PK will be collected at the same time point.

  0, 4 days.

• Elimination half-life (t1/2)

  Biological sample including blood, urine, faeces for PK will be collected at the same time point.

  0, 4 days.

• clearance (CL)

  Biological sample including blood, urine, faeces for PK will be collected at the same time point.

  0, 4 days.

• Volume of distribution (Vd)

  Biological sample including blood, urine, faeces for PK will be collected at the same time point.

  0, 4 days.

Secondary Outcomes (1)

• 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

Study Arms (1)

Ginkgolides Meglumine Injection

EXPERIMENTAL

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.

Drug: Ginkgolides Meglumine Injection

Interventions

Ginkgolides Meglumine Injection DRUG

25 mg, ivdrip, once.

Ginkgolides Meglumine Injection

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jiangsu Kanion Pharmaceutical Co., Ltd: lead
• Beijing Bionovo Medicine Development Co., Ltd.: collaborator

Study Sites (1)

The first affiliated hospital with Nanjing Medical University

Nanjing, Jiangsu, 201129, China

Location

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Ou Ning

  The First Affiliated Hospital with Nanjing Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2014
• First Posted: January 27, 2014
• Study Start: February 1, 2014
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: July 15, 2014

Record last verified: 2013-12

Locations

CN (1)