Evidence map›Paper›PMID 39377925›Full record

Trial reportNaunyn-Schmiedeberg's archives of pharmacology2025

A single-dose, randomized, crossover bioequivalence study of levamlodipine besilate tablets in healthy subjects.

Qiaohuan Deng, Debin Yang, Yang Cheng, Zhengzhi Liu, Yannan Zhou, Yanli Wang, Zhengjie Su, Haimiao Yang

Abstract readClinical Trial, Phase IEquivalence TrialRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Naunyn-Schmiedeberg's archives of pharmacology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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.

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. 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

8 authors.

Qiaohuan DengPhase I Clinical Trial Laboratory, Affiliated Hospital to Changchun University of Chinese Medicine, Changchun, China.
Debin YangPharmaceutical Research Center, Disha Pharmaceutical Group Co., Ltd, Weihai, China.
Yang ChengPhase I Clinical Trial Laboratory, Affiliated Hospital to Changchun University of Chinese Medicine, Changchun, China.
Zhengzhi LiuPhase I Clinical Trial Laboratory, Affiliated Hospital to Changchun University of Chinese Medicine, Changchun, China.
Yannan ZhouPhase I Clinical Trial Laboratory, Affiliated Hospital to Changchun University of Chinese Medicine, Changchun, China.
Yanli WangPhase I Clinical Trial Laboratory, Affiliated Hospital to Changchun University of Chinese Medicine, Changchun, China.
Zhengjie SuPhase I Clinical Trial Laboratory, Affiliated Hospital to Changchun University of Chinese Medicine, Changchun, China.
Haimiao YangPhase I Clinical Trial Laboratory, Affiliated Hospital to Changchun University of Chinese Medicine, Changchun, China. haimiaoyang@outlook.com.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Levamlodipine, the levorotatory form of amlodipine racemate, has a blood pressure-lowering effect that is twice that of the racemate. The study aims to establish a foundation for the clinical application of the test drug by conducting a phase I clinical bioequivalence trial, comparing its bioequivalence and safety with the reference drug in healthy Chinese subjects. Recruiting 26 healthy subjects for separate bioequivalence trials in both fasting and fed conditions. The subjects will orally administer 2.5-mg test drug and 5-mg reference drug. A chiral method was used for bioanalytics and liquid chromatography-tandem mass spectrometry was employed to quantify the (S)-amlodipine concentrations at various time points after administration. In fasting condition, the geometric mean ratios (GMRs) for the primary pharmacokinetic parameters C

Indexed as

AmlodipineAntihypertensive AgentsCalcium Channel BlockersAdministration, OralAdultArea Under CurveCross-Over StudiesFastingFemaleHealthy VolunteersHumansMaleNiacinTabletsTherapeutic EquivalencyYoung AdultAmlodipineAntihypertensive AgentsCalcium Channel BlockerslevamlodipineNiacinTabletsAmlodipineBioequivalenceHypertensionPharmacokineticsSafety

Identifiers

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.