Evidence map›Paper›PMID 38615091›Full record

ArticleClinical drug investigation2024

Pharmacokinetic Interactions Between Tegoprazan and the Combination of Clarithromycin, Amoxicillin and Bismuth in Healthy Chinese Subjects: An Open-Label, Single-Center, Multiple-Dosage, Self-Controlled, Phase I Trial.

Yujing Du, Lixiu Yu, Bin Deng, Qinying Li, Junrui Hu, Linjie Li, Yusen Xu, Liangwei Song, Fang Xie, Yinghui Wang and 4 more

Abstract readClinical Trial, Phase I
PubMed Publisher
In one paragraph

Article in Clinical drug investigation, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed, 1 pooled it
0.6field-weighted citation impact, top 35% 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

1 citing paper in PubMed, 1 synthesis or guideline pooled it, 1 citations in OpenAlex.

  1. Pooled it
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

14 authors at 2 institutions in 1 country.

Yujing Du *Department of Pharmacy, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, No. 1277, Jiefang Avenue, Wuhan, 430022, Hubei, China.
Lixiu Yu *Department of Pharmacy, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, No. 1277, Jiefang Avenue, Wuhan, 430022, Hubei, China.
Bin DengDepartment of Pharmacy, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, No. 1277, Jiefang Avenue, Wuhan, 430022, Hubei, China.
Qinying LiDepartment of Pharmacy, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, No. 1277, Jiefang Avenue, Wuhan, 430022, Hubei, China.
Junrui HuDepartment of Pharmacy, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, No. 1277, Jiefang Avenue, Wuhan, 430022, Hubei, China.
Linjie LiDepartment of Pharmacy, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, No. 1277, Jiefang Avenue, Wuhan, 430022, Hubei, China.
Yusen XuDepartment of Pharmacy, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, No. 1277, Jiefang Avenue, Wuhan, 430022, Hubei, China.
Liangwei SongShandong Luoxin Pharmaceutical Group Co., Ltd, Linyi, 276017, Shandong, China.
Fang XieShandong Luoxin Pharmaceutical Group Co., Ltd, Linyi, 276017, Shandong, China.
Yinghui WangShandong Luoxin Pharmaceutical Group Co., Ltd, Linyi, 276017, Shandong, China.
Yuhao ChenShandong Luoxin Pharmaceutical Group Co., Ltd, Linyi, 276017, Shandong, China.
Chengxin LiuShandong Luoxin Pharmaceutical Group Co., Ltd, Linyi, 276017, Shandong, China.
Xuejia ZhaiDepartment of Pharmacy, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, No. 1277, Jiefang Avenue, Wuhan, 430022, Hubei, China. zhaixuejia@hust.edu.cn.
Yongning LuDepartment of Pharmacy, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, No. 1277, Jiefang Avenue, Wuhan, 430022, Hubei, China. luyn_union@163.com.ORCID http://orcid.org/0000-0001-7172-9913
Union Hospital · CNLuye Pharma (China) · CN

Funding

Chinese Pharmaceutical Association CPA-Z05-ZC-2022-002Key Research and Development Plan of Hubei Province 2023BCB030
6 · The paper itself

Abstract

backgroundTegoprazan is a potassium-competitive acid blocker that inhibits gastric acid and which may be used for eradicating Helicobacter pylori. This study focuses on the pharmacokinetic interaction and safety between tegoprazan and the combination of clarithromycin, amoxicillin and bismuth in healthy Chinese subjects.

methodsAn open-label, three-period, single-center, multiple-dosage, single-sequence, phase I trial was conducted in 22 healthy subjects. In period 1, the subjects took tegoprazan 50 mg twice daily for 7 days, and in period 2 they were administered clarithromycin 500 mg, amoxicillin 1000 mg and bismuth potassium citrate 600 mg twice daily for 7 days (days 14-20). Tegoprazan, clarithromycin, amoxicillin and bismuth potassium citrate were then administered in combination for 7 days (days 21-27) in period 3. Blood samples were collected up to 12 h after the last dose of each period. Safety assessments were performed in each period.

resultsThe geometric mean ratios (GMRs) [90% confidence interval (CI)] of maximum plasma concentration at steady state (C

conclusionThe plasma exposure of tegoprazan, M1, 14-hydroxyclarithromycin and bismuth was increased after the coadministration of tegoprazan, clarithromycin, amoxicillin and bismuth. The coadministration exhibited favorable safety and tolerability. CLINICAL TRIALS REGISTRATION: CTR20230643.

Indexed as

AmoxicillinBenzene DerivativesBismuthClarithromycinDrug InteractionsAdultAnti-Bacterial AgentsArea Under CurveChinaEast Asian PeopleFemaleHealthy VolunteersHumansImidazolesMaleProton Pump InhibitorsAmoxicillinAnti-Bacterial AgentsBenzene DerivativesBismuthClarithromycinImidazolesProton Pump Inhibitorstegoprazan

Identifiers

PMID38615091
OpenAlexW4394786465

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.