Evidence map›Paper›PMID 33213527›Full record

Trial reportBMC pharmacology & toxicology2020

Bioequivalence of levamlodipine besylate tablets in healthy Chinese subjects: a single-dose and two-period crossover randomized study.

Xin Li, Chenjing Wang, Ting Li, Yanping Liu, Shuqin Liu, Ye Tao, Yaping Ma, Xiaomeng Gao, Yu Cao

Registry-linked trialOpen access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in BMC pharmacology & toxicology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04411875 (Bioequivalence of Levamlodipine Besylate Tablets in Healthy Chinese Subjects), which is not on this map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
0.7field-weighted citation impact, top 25% 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.

NCT04411875 phase1completednot on this map

Bioequivalence of Levamlodipine Besylate Tablets in Healthy Chinese Subjects: A Single-dose and Two-period Crossover Study

TypeinterventionalSponsorThe Affiliated Hospital of Qingdao UniversityRan2018 to 2019Enrolled48ConditionsHealthy SubjectsArmsAmlodipine 10 mg, Levamlodipine 5 mg
3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 13 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Trial
  4. Article
  5. Observational
  6. 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

9 authors at 1 institution in 1 country.

Xin LiPhase I Clinical Research Center, The Affiliated Hospital of Qingdao University, Qingdao, 266003, China.
Chenjing WangPhase I Clinical Research Center, The Affiliated Hospital of Qingdao University, Qingdao, 266003, China.
Ting LiPhase I Clinical Research Center, The Affiliated Hospital of Qingdao University, Qingdao, 266003, China.
Yanping LiuPhase I Clinical Research Center, The Affiliated Hospital of Qingdao University, Qingdao, 266003, China.
Shuqin LiuPhase I Clinical Research Center, The Affiliated Hospital of Qingdao University, Qingdao, 266003, China.
Ye TaoPhase I Clinical Research Center, The Affiliated Hospital of Qingdao University, Qingdao, 266003, China.
Yaping MaPhase I Clinical Research Center, The Affiliated Hospital of Qingdao University, Qingdao, 266003, China.
Xiaomeng GaoPhase I Clinical Research Center, The Affiliated Hospital of Qingdao University, Qingdao, 266003, China.
Yu CaoPhase I Clinical Research Center, The Affiliated Hospital of Qingdao University, Qingdao, 266003, China. caoyu1767@126.com.ORCID 0000-0002-3980-8133
Qingdao University · CN

Funding

National Major Science and Technology Projects of China 2020ZX09201-018Postdoctoral Research Foundation of China 2016M602100
6 · The paper itself

Abstract

backgroundLevamlodipine, a calcium channel blocker, has been show act as a cardiovascular drug. To compare the pharmacokinetic parameters between levamlodipine (test formulation) at a single dose of 5 mg and amlodipine (reference formulation) at a single dose of 10 mg, the bioequivalence study was carried out.

methodsA single-dose randomized, open-label, two-period crossover study was designed in healthy Chinese subjects. 48 subjects were divided into fasted and fed groups equally. The subjects randomly received the test or reference formulations at the rate of 1:1. Following a 21-day washout period, the alternative formulations were received. The blood samples were collected at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 24, 36, 48, 72, 96, 120, 144, 168 h later. Liquid chromatography-tandem mass spectrometry (LC-MS/MS) was applied to determine the plasma concentrations of levamlodipine. Adverse events were recorded.

resultsThe 90% confidence intervals (CIs) of the ratio of geometric means (GMRs) of C

conclusionThe trial confirmed that levamlodipine at a single dose of 5 mg and amlodipine at a single dose of 10 mg were bioequivalent under both fasted condition and fed condition.

trial registrationCinicaltrials, NCT04411875 . Registered 3 June 2020 - Retrospectively registered.

Indexed as

Asian PeopleAdultAmlodipineCardiovascular AgentsCross-Over StudiesFemaleHealthy VolunteersHumansMaleMiddle AgedNiacinTabletsTherapeutic EquivalencyYoung AdultAmlodipineCardiovascular AgentslevamlodipineNiacinTabletsAmlodipineBioequivalenceLevamlodipinePharmacokinetics

Identifiers

PMID33213527
PMCPMC7678077
OpenAlexW3098355829

What OpenQuestion holds

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Registered trials

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.