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Ischemic StrokePhase 4NCT02046031

Preliminary Study of Pharmacokinetics of Ginkgolides Meglumine Injection.

A Phase 4 study testing Ginkgolides Meglumine Injection in people with Ischemic Stroke, run by Jiangsu Kanion Pharmaceutical Co., Ltd at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 40 yearsHealthy volunteers can take part
Conditions the study is for
Ischemic Stroke
What is being tested?
Ginkgolides Meglumine Injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
4 participants
Where
1 siteChina
Study dates
Feb 2014to Jun 2014
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 40 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 15Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site

  • The first affiliated hospital with Nanjing Medical University

    Nanjing, Jiangsu, 201129

Other trials in China

About this study

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.

Read the 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
Ischemic Stroke
Being tested
Ginkgolides Meglumine Injection
Keywords
Ischemic stroke, safety, Pharmacokinetics, Ginkgolides Meglumine Injection
Medical subject headings
Ischemic Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ginkgolides Meglumine InjectionDrug

    25 mg, ivdrip, once.

Study groups in NCT02046031
Study groupRoleWhat they receive
Ginkgolides Meglumine InjectionExperimentalIntravenous 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.
Receives: Drug: Ginkgolides Meglumine Injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 0, 4 days.

  2. Time to maximum plasma concentration (Tmax)

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

    Measured: 0, 4 days.

  3. Area under the curve (AUC)

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

    Measured: 0, 4 days.

  4. Elimination half-life (t1/2)

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

    Measured: 0, 4 days.

  5. clearance (CL)

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

    Measured: 0, 4 days.

  6. Volume of distribution (Vd)

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

    Measured: 0, 4 days.

Secondary outcomes (1)

  1. 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.

    Measured: 0, 4days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2014 (estimated)
  2. Study startFeb 2014
  3. Primary completionJun 2014
  4. Study completionJun 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
4 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02046031
Sponsor's protocol ID
Z-YXPU-ZS-IV3
Status last verified
Dec 2013
First submitted
19 Jan 2014
Last updated
15 Jul 2014
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Ginkgolides Meglumine Injection in people with Ischemic Stroke, run by Jiangsu Kanion Pharmaceutical Co., Ltd at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum plasma concentration (Cmax) (time frame: 0, 4 days.). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02046031.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2014.

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