Evidence map›Paper›PMID 37208866›Full record

Trial reportPharmacology research & perspectives2023

Effect of a high-fat and high-calorie food on the pharmacokinetics of a novel, potent GABA analog HSK16149 in healthy subjects.

Qingqing Wu, Huijuan Zhu, Rong Song, Mengqi Zhang, Fangqiong Li, Weifang Zeng, Wei Wang, Jingying Jia, Chen Yu, Yanmei Liu

Open access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Pharmacology research & perspectives, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
1.1field-weighted citation impact, top 24% 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

5 citing papers in PubMed, 6 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Article
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  5. Article
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

10 authors at 2 institutions in 1 country.

Qingqing WuDrug Clinical Trial Center, Shanghai Xuhui Central Hospital, Shanghai, China.ORCID https://orcid.org/0000-0003-4105-290X
Huijuan ZhuDrug Clinical Trial Center, Shanghai Xuhui Central Hospital, Shanghai, China.
Rong SongDrug Clinical Trial Center, Shanghai Xuhui Central Hospital, Shanghai, China.
Mengqi ZhangDrug Clinical Trial Center, Shanghai Xuhui Central Hospital, Shanghai, China.
Fangqiong LiHaisco Pharmaceutical Group Co., Ltd., Chengdu, China.
Weifang ZengHaisco Pharmaceutical Group Co., Ltd., Chengdu, China.
Wei WangDrug Clinical Trial Center, Shanghai Xuhui Central Hospital, Shanghai, China.
Jingying JiaDrug Clinical Trial Center, Shanghai Xuhui Central Hospital, Shanghai, China.ORCID https://orcid.org/0000-0002-2492-3219
Chen YuDrug Clinical Trial Center, Shanghai Xuhui Central Hospital, Shanghai, China.
Yanmei LiuDrug Clinical Trial Center, Shanghai Xuhui Central Hospital, Shanghai, China.
Shanghai Xuhui Central Hospital · CNChina National Pharmaceutical Group Corporation (China) · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

HSK16149 is a novel, potent gamma-aminobutyric acid (GABA) analog for the treatment of neuropathic pain. The purpose of this study was to assess the effect of a high-fat and high-calorie meal on the pharmacokinetics of HSK16149 in healthy Chinese subjects. An open-label, two-period crossover design was applied in this study. Twenty-six subjects were enrolled and were randomly divided into two groups: a fasted-fed group and a fed-fasted group, with 13 subjects in each group. Subjects took a single oral dose of 45 mg of HSK16149 under fasted or fed conditions on Day 1 and Day 4. A series of blood samples were collected for PK analysis. Safety was evaluated throughout the study by physical examinations, clinical laboratory tests, 12-lead ECGs, vital signs, and adverse events (AEs). The parameters AUC

Indexed as

FastingFood-Drug InteractionsBiological AvailabilityHealthy VolunteersHumansTherapeutic Equivalencyfood effecthealthy subjectshigh-fatHSK16149pharmacokineticssafety

Identifiers

PMID37208866
PMCPMC10199234
OpenAlexW4377142687

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.