Evidence map›Paper›PMID 38345697›Full record

Trial reportDrugs in R&D2024

Pharmacokinetic and Safety Study of Bismuth Potassium Citrate Formulations in Healthy Subjects.

Hong-Yu Luo, Shuo-Guo Xu, Li-Chen Gao, Hui-Zhi Long, Zi-Wei Zhou, Feng-Jiao Li, Shang-Ming Dai, Jin-Da Hu, Yu Su, Yan Cheng

Open access · goldAbstract readClinical Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Drugs in R&D, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact, top 97% 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

0 citing papers in PubMed, 0 citations in OpenAlex.

No citing paper in PubMed yet.

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.

Hong-Yu Luo *Department of Pharmacy, School of Pharmacy, Phase I Clinical Trial Centre, The Affiliated Changsha Central Hospital, Hengyang Medical School, University of South China, Changsha, China.ORCID http://orcid.org/0000-0003-3357-9154
Shuo-Guo Xu *Department of Pharmacy, School of Pharmacy, Phase I Clinical Trial Centre, The Affiliated Changsha Central Hospital, Hengyang Medical School, University of South China, Changsha, China.
Li-Chen GaoDepartment of Pharmacy, School of Pharmacy, Phase I Clinical Trial Centre, The Affiliated Changsha Central Hospital, Hengyang Medical School, University of South China, Changsha, China. 89206346@qq.com.
Hui-Zhi LongDepartment of Pharmacy, School of Pharmacy, Phase I Clinical Trial Centre, The Affiliated Changsha Central Hospital, Hengyang Medical School, University of South China, Changsha, China.
Zi-Wei ZhouDepartment of Pharmacy, School of Pharmacy, Phase I Clinical Trial Centre, The Affiliated Changsha Central Hospital, Hengyang Medical School, University of South China, Changsha, China.
Feng-Jiao LiDepartment of Pharmacy, School of Pharmacy, Phase I Clinical Trial Centre, The Affiliated Changsha Central Hospital, Hengyang Medical School, University of South China, Changsha, China.
Shang-Ming DaiDepartment of Pharmacy, School of Pharmacy, Phase I Clinical Trial Centre, The Affiliated Changsha Central Hospital, Hengyang Medical School, University of South China, Changsha, China.
Jin-Da HuDepartment of Pharmacy, School of Pharmacy, Phase I Clinical Trial Centre, The Affiliated Changsha Central Hospital, Hengyang Medical School, University of South China, Changsha, China.
Yu SuHunan Warrant Pharmaceutical Co., Ltd., Changsha, China.
Yan ChengDepartment of Pharmacy, School of Pharmacy, Phase I Clinical Trial Centre, The Affiliated Changsha Central Hospital, Hengyang Medical School, University of South China, Changsha, China.
Changsha Central Hospital · CNCentral South University · CN

Funding

Changsha Central Hospital Affiliated to University of South China Foundation of key Program YNKY202205Hunan Provincial Natural Science Foundation of China 2021JJ30753Scientific Research Fund of Hunan Provincial Education Department 22A0320
6 · The paper itself

Abstract

backgroundPotassium bismuth citrate is a gastric mucosal protector and a key drug for treating peptic ulcers.

objectiveTo evaluate the pharmacokinetic characteristics and safety of 120-mg bismuth potassium citrate formulations administered orally under fasting conditions in healthy Chinese subjects.

methodA single-center open two-cycle trial was conducted on 12 healthy subjects who received a single oral dose of 120 mg of bismuth potassium citrate. The plasma concentration of bismuth was determined using a validated inductively coupled plasma mass spectrometry (ICP‒MS) method. The pharmacokinetic parameters, including maximum serum concentration (C

resultsThe ratios of the least square geometric mean ratio between the test (T) and reference (R) formulations for C

conclusionThe concentration of bismuth in the blood of healthy subjects in the T formulation was not greater than that in the R formulation. Similarly, the safety of oral administration of 120 mg of bismuth potassium citrate formulations to healthy subjects was good. The trial registration number (TRN) was [2018] 013, 6 December 2018.

Indexed as

BismuthOrganometallic CompoundsAdministration, OralAdultArea Under CurveFemaleHealthy VolunteersHumansMaleYoung AdultBismuthOrganometallic Compounds

Identifiers

PMID38345697
PMCPMC11035504
OpenAlexW4391754172

What Socratic 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 Socratic graph.