Evidence map›Paper›PMID 28105513›Full record

Trial reportEuropean journal of clinical pharmacology2017

Pharmacokinetics of ginkgolides A, B and K after single and multiple intravenous infusions and their interactions with midazolam in healthy Chinese male subjects.

Feng Shao, Hongwen Zhang, Lijun Xie, Juan Chen, Sufeng Zhou, Jinsong Zhang, Jinru Lv, Weiwen Hao, Yunsu Ma, Yun Liu and 2 more

Abstract readRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in European journal of clinical pharmacology, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
1.2field-weighted citation impact, top 20% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 14 citations in OpenAlex.

  1. Trial
  2. Review
  3. Review
  4. Article
  5. Article
  6. Toxicity Potential of Nutraceuticals.Methods in molecular biology (Clifton, N.J.) · 2025
    Article
  7. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors at 2 institutions in 1 country.

Feng ShaoPhase I Clinical Trial Unit, First Affiliated Hospital-Nanjing Medical University, Nanjing, Jiangsu, 210029, China.
Hongwen ZhangPhase I Clinical Trial Unit, First Affiliated Hospital-Nanjing Medical University, Nanjing, Jiangsu, 210029, China.
Lijun XiePhase I Clinical Trial Unit, First Affiliated Hospital-Nanjing Medical University, Nanjing, Jiangsu, 210029, China.
Juan ChenPhase I Clinical Trial Unit, First Affiliated Hospital-Nanjing Medical University, Nanjing, Jiangsu, 210029, China.
Sufeng ZhouPhase I Clinical Trial Unit, First Affiliated Hospital-Nanjing Medical University, Nanjing, Jiangsu, 210029, China.
Jinsong ZhangPhase I Clinical Trial Unit, First Affiliated Hospital-Nanjing Medical University, Nanjing, Jiangsu, 210029, China.
Jinru LvPhase I Clinical Trial Unit, First Affiliated Hospital-Nanjing Medical University, Nanjing, Jiangsu, 210029, China.
Weiwen HaoPhase I Clinical Trial Unit, First Affiliated Hospital-Nanjing Medical University, Nanjing, Jiangsu, 210029, China.
Yunsu MaPhase I Clinical Trial Unit, First Affiliated Hospital-Nanjing Medical University, Nanjing, Jiangsu, 210029, China.
Yun LiuPhase I Clinical Trial Unit, First Affiliated Hospital-Nanjing Medical University, Nanjing, Jiangsu, 210029, China.
Ning OuPhase I Clinical Trial Unit, First Affiliated Hospital-Nanjing Medical University, Nanjing, Jiangsu, 210029, China. zhousfhappy@126.com.
Wei XiaoState Key Laboratory of New-tech for Chinese Medicine Pharmaceutical Process, Jiangsu Kanion Pharmaceutical CO. LTD, Lianyungang, Jiangsu, 222001, China. shaofeng33@yahoo.com.
Nanjing Medical University · CNKanion Pharmaceutical (China) · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeGinkgo terpene lactones meglumine injection (GMI) is a novel preparation of traditional Chinese medicine that contains ginkgolides A, B and K (GA, GB, GK, respectively) as its primary components. In this study we evaluated the safety, tolerability and pharmacokinetics of these three ginkgolides after single and multiple intravenous infusions of GMI. We also investigated the effect of GMI on cytochrome P450 3A4 (CYP3A4) in healthy Chinese volunteers.

methodsIn this open-label, placebo-controlled study 15 subjects were randomly assigned to receive GMI or matched placebo (4:1 ratio). All subjects first received midazolam (MDZ) on day 1, followed by a 6-day washout. On Day 8, the subjects were started on once-daily dosing of either GMI or placebo for 14 days. Lastly, on Day 22 the subjects were given second dose of MDZ + GMI or MDZ + placebo. Plasma concentrations of ginkgolides, MDZ and its metabolite 1-hydroxy midazolam were quantified.

resultsThe steady-state conditions of GA, GB and GK were achieved after 6 days of daily dosing. Following a single dose of GMI (Day 8) the area under the concentration-timecurve from zero to 24 h after administration (AUC

conclusionsOur results show that GMI was well tolerated during the entire study. There was no systemic accumulation and no significant effects on the pharmacokinetics of MDZ in healthy Chinese male subjects after repeated dosing of GMI.

Indexed as

AdultDrug InteractionsGinkgolidesHumansInfusions, IntravenousMaleMidazolamPlacebosReproducibility of ResultsYoung AdultGinkgolidesMidazolamPlacebosCYP3A4Drug–drug interactionGinkgolide KGinkgolides A, B, CMidazolamPharmacokinetics

Identifiers

PMID28105513
OpenAlexW2579378131

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.