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Preliminary Study of Pharmacokinetics of Ginkgolides Meglumine Injection.

13. juli 2014 opdateret af: Jiangsu Kanion Pharmaceutical Co., Ltd
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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

4

Fase

  • Fase 4

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Kina
    • Jiangsu
      • Nanjing, Jiangsu, Kina, 201129
        • The First Affiliated Hospital with Nanjing Medical University

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 40 år (Voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Ginkgolides Meglumine Injection
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.
Medicin: Ginkgolides Meglumine Injection
25 mg, ivdrip, once.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Maximum plasma concentration (Cmax)
Tidsramme: 0, 4 days.
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)
Tidsramme: 0, 4 days.
Biological sample including blood, urine, faeces for PK will be collected at the same time point.
0, 4 days.
Area under the curve (AUC)
Tidsramme: 0, 4 days.
Biological sample including blood, urine, faeces for PK will be collected at the same time point.
0, 4 days.
Elimination half-life (t1/2)
Tidsramme: 0, 4 days.
Biological sample including blood, urine, faeces for PK will be collected at the same time point.
0, 4 days.
clearance (CL)
Tidsramme: 0, 4 days.
Biological sample including blood, urine, faeces for PK will be collected at the same time point.
0, 4 days.
Volume of distribution (Vd)
Tidsramme: 0, 4 days.
Biological sample including blood, urine, faeces for PK will be collected at the same time point.
0, 4 days.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Safety assessments will be based on adverse event reports and the results of vital sign measurements, electrocardiogram, Electrocardiogram monitoring and clinical laboratory tests.
Tidsramme: 0, 4days
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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Jiangsu Kanion Pharmaceutical Co., Ltd

Samarbejdspartnere

Beijing Bionovo Medicine Development Co., Ltd.

Efterforskere

  • Ledende efterforsker: Ou Ning, The First Affiliated Hospital with Nanjing Medical University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. februar 2014

Primær færdiggørelse (Faktiske)

1. juni 2014

Studieafslutning (Faktiske)

1. juni 2014

Datoer for studieregistrering

Først indsendt

19. januar 2014

Først indsendt, der opfyldte QC-kriterier

23. januar 2014

Først opslået (Skøn)

27. januar 2014

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

15. juli 2014

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

13. juli 2014

Sidst verificeret

1. december 2013

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • Z-YXPU-ZS-IV3

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Ginkgolides Meglumine Injection

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Betingelser

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Placeringer

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