Evidence map›Paper›PMID 40433999›Full record

ArticleFrontiers in pharmacology2025

Evaluation of the pharmacokinetic interactions of montmorillonite powder or loperamide on pyrotinib in healthy volunteers.

Yike Wang, Dai Li, Tong Zhang, Sumei Xu, Yanxin Zhang, Kaijing Zhao, Shaorong Li, Kai Shen, Xiaomin Li, Pingsheng Xu

Registry-linked trialAbstract read
In one paragraph

Article in Frontiers in pharmacology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05252546 (A Single-centre, Open, Single-dose, Fixed-sequence Study to Investigate the Effect of Montmorillonite Power or Loperamide on the Pharmacokinetics of Pyrotinib in Healthy Chinese Adult Subjects), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
–field-weighted citation impact
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.

NCT05252546 phase1completednot on this map

A Single-centre, Open, Single-dose, Fixed-sequence Study to Investigate the Effect of Montmorillonite Power or Loperamide on the Pharmacokinetics of Pyrotinib in Healthy Chinese Adult Subjects

TypeinterventionalSponsorJiangsu HengRui Medicine Co., Ltd.Ran2022 to 2022Enrolled36ConditionsHER2-positive Recurrent / Metastatic Breast CancerArmspyrotinib tablet, Montmorillonite Power, Loperamide
3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Article
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  3. 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.

Yike WangDepartment of Clinical Pharmacology, Jiangsu Hengrui Pharmaceuticals Co., Ltd., Shanghai, China.
Dai LiPhase I Clinical Trial Center, Xiangya Hospital, Central South University, Changsha, China.
Tong ZhangDepartment of Clinical Pharmacology, Jiangsu Hengrui Pharmaceuticals Co., Ltd., Shanghai, China.
Sumei XuPhase I Clinical Trial Center, Xiangya Hospital, Central South University, Changsha, China.
Yanxin ZhangPhase I Clinical Trial Center, Xiangya Hospital, Central South University, Changsha, China.
Kaijing ZhaoDepartment of Clinical Pharmacology, Jiangsu Hengrui Pharmaceuticals Co., Ltd., Shanghai, China.
Shaorong LiDepartment of Clinical Pharmacology, Jiangsu Hengrui Pharmaceuticals Co., Ltd., Shanghai, China.
Kai ShenDepartment of Clinical Pharmacology, Jiangsu Hengrui Pharmaceuticals Co., Ltd., Shanghai, China.
Xiaomin LiPhase I Clinical Trial Center, Xiangya Hospital, Central South University, Changsha, China.
Pingsheng XuPhase I Clinical Trial Center, Xiangya Hospital, Central South University, Changsha, China.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Aims: To investigate the potential pharmacokinetic interactions of montmorillonite powder or loperamide on pyrotinib. Methods: This study was a single-center, open-label, single-dose, fixed-sequence clinical trial conducted with healthy volunteers. The participants were divided into two groups (A and B), each consisting of 18 subjects. Both groups received a single oral dose of 400 mg of pyrotinib on day 1. On day 9, Group A received a single dose of 400 mg of pyrotinib followed by 3 g of montmorillonite powder 2 h later, while Group B received a single dose of pyrotinib and 4 mg of loperamide after breakfast on day 9, followed by single oral doses of 2 mg of loperamide at 2 and 4 h post-administration. Blood samples were collected to determine pyrotinib blood concentrations. Results: In Group A, the combination treatment with montmorillonite powder resulted in a decrease in C Conclusion: Even when montmorillonite powder was administered 2 h after pyrotinib dosing, it still reduced systemic exposure of pyrotinib by 32.4% in AUC Clinical trial registration: [ClinicalTrials.gov], identifier [NCT05252546].

Indexed as

diarrhealoperamidemontmorillonite powderpharmacokineticspyrotinib

Identifiers

PMID40433999
PMCPMC12104674

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