Evidence map›Paper›PMID 36135935›Full record

Trial reportAnnals of medicine2022

Bioequivalence and safety evaluation of two preparations of metformin hydrochloride sustained-release tablets (Boke

Ming-Li Sun, Chen Liu, Hai-Hong Bai, Ya-Li Wei, Wei Zhang, Hui-Juan Liu, Yin-Juan Li, Long Liu, Yu Wang, Yuan-Xv Tong and 3 more

Open access · goldAbstract readClinical Trial, Phase IRandomized Controlled Trial
In one paragraph

Trial report in Annals of medicine, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
3.0field-weighted citation impact, top 9% 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

3 citing papers in PubMed, 8 citations in OpenAlex.

  1. Trial
  2. Article
  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

13 authors at 2 institutions in 1 country.

Ming-Li SunPhase I Clinical Trial Centre, Beijing Shijitan Hospital Affiliated to Capital Medical University, Beijing, P. R. China.ORCID 0000-0002-0535-2545
Chen LiuPhase I Clinical Trial Centre, Beijing Shijitan Hospital Affiliated to Capital Medical University, Beijing, P. R. China.
Hai-Hong BaiPhase I Clinical Trial Centre, Beijing Shijitan Hospital Affiliated to Capital Medical University, Beijing, P. R. China.
Ya-Li WeiPhase I Clinical Trial Centre, Beijing Shijitan Hospital Affiliated to Capital Medical University, Beijing, P. R. China.
Wei ZhangPhase I Clinical Trial Centre, Beijing Shijitan Hospital Affiliated to Capital Medical University, Beijing, P. R. China.
Hui-Juan LiuPhase I Clinical Trial Centre, Beijing Shijitan Hospital Affiliated to Capital Medical University, Beijing, P. R. China.
Yin-Juan LiPhase I Clinical Trial Centre, Beijing Shijitan Hospital Affiliated to Capital Medical University, Beijing, P. R. China.
Long LiuPhase I Clinical Trial Centre, Beijing Shijitan Hospital Affiliated to Capital Medical University, Beijing, P. R. China.
Yu WangPhase I Clinical Trial Centre, Beijing Shijitan Hospital Affiliated to Capital Medical University, Beijing, P. R. China.
Yuan-Xv TongPhase I Clinical Trial Centre, Beijing Shijitan Hospital Affiliated to Capital Medical University, Beijing, P. R. China.
Qian GaoDivision of Medicine, China Resources Double-Crane Pharmaceutical Co. Ltd., Beijing, P. R. China.
Qian-Ying LiuResearch and Development Department, China Resources Double-Crane Pharmaceutical Co. Ltd., Beijing, P. R. China.
Xinghe WangPhase I Clinical Trial Centre, Beijing Shijitan Hospital Affiliated to Capital Medical University, Beijing, P. R. China.
Capital Medical University · CNChina Resources (China) · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAs per the National Medical Products Administration (NMPA) requirements, the quality and efficacy of generic drugs must be consistent with those of the innovator drug. We aimed to evaluate the bioequivalence and safety of generic metformin hydrochloride sustained-release (MH-SR) tablets (Boke MATERIALS AND

methodsWe performed a bioequivalence and safety assessment of MH-SR (500 mg/tablet) and Glucophage

resultsThe 90% CIs of the test/reference preparation for key pharmacokinetic parameters were 97.36-108.30% for AUC

conclusionsMH-SR (500 mg/tablet) and Glucophage

Indexed as

MetforminAdultChinaDelayed-Action PreparationsDrugs, GenericFastingHealthy VolunteersHumansTabletsTherapeutic EquivalencyDelayed-Action PreparationsDrugs, GenericMetforminTabletsBioequivalencecrossover trialsfasting conditionsmetformin hydrochloridepharmacokinetics

Identifiers

PMID36135935
PMCPMC9521607
OpenAlexW4296661876

What Socratic holds

Textmetadata
LicenceCC BY
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 Socratic graph.