Evidence map›Paper›PMID 33355910›Full record

Trial reportClinical drug investigation2021

Safety, Tolerability and Pharmacokinetics of Single Ascending and Multiple Oral Doses of Tegoprazan in Healthy Chinese Subjects.

Jinjie He, Guoying Cao, Jicheng Yu, Jingjing Wang, Nengneng Cheng, Jufang Wu, Jing Zhang, Xiaojie Wu, Basheng Zhang, Jiayan Lu and 1 more

Abstract readRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Clinical drug investigation, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed, 1 pooled it
1.1field-weighted citation impact, top 21% 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

15 citing papers in PubMed, 1 synthesis or guideline pooled it, 22 citations in OpenAlex.

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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

11 authors at 1 institution in 1 country.

Jinjie He *Phase I Clinical Research Center, Huashan Hospital, Fudan University, No.12 in Wurumuqi Road, Jingan Area, Shanghai, China.
Guoying Cao *Phase I Clinical Research Center, Huashan Hospital, Fudan University, No.12 in Wurumuqi Road, Jingan Area, Shanghai, China.
Jicheng YuPhase I Clinical Research Center, Huashan Hospital, Fudan University, No.12 in Wurumuqi Road, Jingan Area, Shanghai, China.
Jingjing WangPhase I Clinical Research Center, Huashan Hospital, Fudan University, No.12 in Wurumuqi Road, Jingan Area, Shanghai, China.
Nengneng ChengSchool of Pharmacy, Fudan University, Shanghai, China.
Jufang WuPhase I Clinical Research Center, Huashan Hospital, Fudan University, No.12 in Wurumuqi Road, Jingan Area, Shanghai, China.
Jing ZhangPhase I Clinical Research Center, Huashan Hospital, Fudan University, No.12 in Wurumuqi Road, Jingan Area, Shanghai, China. zhangj_fudan@aliyun.com.ORCID http://orcid.org/0000-0003-2966-9149
Xiaojie WuPhase I Clinical Research Center, Huashan Hospital, Fudan University, No.12 in Wurumuqi Road, Jingan Area, Shanghai, China.
Basheng ZhangShandong Luoxin Pharmaceutical Group Stock Co., Ltd., Linyi, China.
Jiayan LuShandong Luoxin Pharmaceutical Group Stock Co., Ltd., Linyi, China.
Shangzhi ChenShandong Luoxin Pharmaceutical Group Stock Co., Ltd., Linyi, China.
Fudan University · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND AND

objectivesTegoprazan is one of the potassium-competitive acid blockers (P-CABs). It exhibits its anti-secretory effects by competitively and reversibly blocking the availability of K

methodsThirty-eight healthy Chinese subjects were recruited in this randomized, single-center, double-blind, placebo-controlled study, with a single ascending dose of 50, 100, 200 mg and a multiple dose of 100 mg for 10 days. The plasma concentration of tegoprazan was determined by a validated liquid chromatography tandem mass spectrometry (LC-MS/MS) method. Pharmacokinetics were evaluated via non-compartmental and compartmental model analysis. Safety was assessed by physical examinations, vital signs, clinical laboratory tests, and electrocardiograms.

resultsNo serious adverse event was observed in this study. After single-dose administration (50, 100 and 200 mg), tegoprazan was rapidly absorbed with a median maximum measure plasma concentration (T

conclusionsTegoprazan was well tolerated in the dose range of 50-200 mg in single- and 100 mg in multiple-dose studies. Tegoprazan shows dose linearity with oral administration after a single dose of 50 to 200 mg and less drug accumulation after 10 days of continuous administration in 100 mg.

Indexed as

Chromatography, LiquidTandem Mass SpectrometryAdministration, OralAdultArea Under CurveAsian PeopleBenzene DerivativesDouble-Blind MethodFemaleHumansImidazolesMaleYoung AdultBenzene DerivativesImidazolestegoprazan

Identifiers

PMID33355910
OpenAlexW3117133150

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.