Evidence map›Paper›PMID 35061235›Full record

ArticleDrugs in R&D2022

Bioequivalence and Safety Assessment of Two Formulations of Metformin Hydrochloride Sustained-Release Tablets (Yuantang

Ming-Li Sun, Hui-Juan Liu, Xiang-Dong Luo, Yu Wang, Wei Zhang, Chen Liu, Xinghe Wang

Open access · goldAbstract readClinical Trial, Phase I
In one paragraph

Article in Drugs in R&D, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
2.3field-weighted citation impact, top 13% 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

2 citing papers in PubMed, 6 citations in OpenAlex.

  1. Trial
  2. Trial
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

7 authors at 2 institutions in 1 country.

Ming-Li SunPhase I Clinical Trial Center, Beijing Shijitan Hospital Affiliated to Capital Medical University, 10 Tieyi Road, Yangfangdian, Haidian District, Beijing, 100038, People's Republic of China.ORCID http://orcid.org/0000-0002-0535-2545
Hui-Juan LiuPhase I Clinical Trial Center, Beijing Shijitan Hospital Affiliated to Capital Medical University, 10 Tieyi Road, Yangfangdian, Haidian District, Beijing, 100038, People's Republic of China.
Xiang-Dong LuoDepartment of Research and Development, Guangdong Sinocorp Pharmaceutical Co., Ltd, Xiang-er Road, Huizhou Industrial Transfer Park, Longmen County, Huizhou, Guangdong Province, 516800, People's Republic of China.
Yu WangPhase I Clinical Trial Center, Beijing Shijitan Hospital Affiliated to Capital Medical University, 10 Tieyi Road, Yangfangdian, Haidian District, Beijing, 100038, People's Republic of China.
Wei ZhangPhase I Clinical Trial Center, Beijing Shijitan Hospital Affiliated to Capital Medical University, 10 Tieyi Road, Yangfangdian, Haidian District, Beijing, 100038, People's Republic of China.
Chen LiuPhase I Clinical Trial Center, Beijing Shijitan Hospital Affiliated to Capital Medical University, 10 Tieyi Road, Yangfangdian, Haidian District, Beijing, 100038, People's Republic of China.
Xinghe WangPhase I Clinical Trial Center, Beijing Shijitan Hospital Affiliated to Capital Medical University, 10 Tieyi Road, Yangfangdian, Haidian District, Beijing, 100038, People's Republic of China. wangxh@bjsjth.cn.
Capital Medical University · CNHuizhou Central People's Hospital · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveThe purpose of this single-center, randomized, open, two-period, two-sequence crossover, single-dose administration, bioequivalence research was to evaluate the bioequivalence and safety of the generic formulations of metformin hydrochloride sustained-release (MH-SR) 500 mg tablets (test preparation [T]: Yuantang

methodsSubjects received 500 mg T/R in each period, with a 7-day washout period. Venous blood samples of 4 mL each were collected from each subject 19 times spanning predose (0 h) to 36 h postdose. The metformin concentration in deproteinized plasma was determined by high-performance liquid chromatography-tandem mass spectrometry. Bioequivalence (80.00-125.00%) was assessed by adjusted geometric mean ratios (GMRs) and two-sided 90% confidence intervals (CIs) of the area under the curve (AUC) and maximum concentration (C

resultsThirty-four volunteers completed the clinical study. The 90% CIs (96.12-105.44% for AUC from time zero to the time of the last measurable concentration [AUC

conclusionsYuantang

Indexed as

MetforminAdministration, OralAdultArea Under CurveChinaCross-Over StudiesDelayed-Action PreparationsFastingHumansTabletsTherapeutic EquivalencyDelayed-Action PreparationsMetforminTablets

Identifiers

PMID35061235
PMCPMC8885941
OpenAlexW4205603880

What Socratic holds

Textmetadata
LicenceCC BY-NC
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.