Evidence mapPaperPMID 33044102Full record

Trial reportThe Journal of international medical research2020

Method for evaluating the human bioequivalence of acarbose based on pharmacodynamic parameters.

Su-Mei Xu, Yu-Ying Xu, Juan Yan, Yi-Fei Zhang, Dai Li, Dan Li, Xiao-Min Li, Jie Guo, Ping-Sheng Xu

Open access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in The Journal of international medical research, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
0.4field-weighted citation impact, top 35% 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

5 citing papers in PubMed, 7 citations in OpenAlex.

  1. Article
  2. Article
  3. Article
  4. Review
  5. 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 2 institutions in 1 country.

Su-Mei XuNational Institution of Drug Clinical Trial, Xiangya Hospital, Central South University, Changsha, Hunan, P. R. China.
Yu-Ying XuNational Institution of Drug Clinical Trial, Xiangya Hospital, Central South University, Changsha, Hunan, P. R. China.
Juan YanNational Institution of Drug Clinical Trial, Xiangya Hospital, Central South University, Changsha, Hunan, P. R. China.
Yi-Fei ZhangSchool of Pharmaceutical Sciences, Sun Yat-sen University, Guangzhou, Guangdong, P. R. China.
Dai LiNational Institution of Drug Clinical Trial, Xiangya Hospital, Central South University, Changsha, Hunan, P. R. China.
Dan LiNational Institution of Drug Clinical Trial, Xiangya Hospital, Central South University, Changsha, Hunan, P. R. China.
Xiao-Min LiNational Institution of Drug Clinical Trial, Xiangya Hospital, Central South University, Changsha, Hunan, P. R. China.
Jie GuoNational Institution of Drug Clinical Trial, Xiangya Hospital, Central South University, Changsha, Hunan, P. R. China.ORCID https://orcid.org/0000-0003-4377-4201
Ping-Sheng XuNational Institution of Drug Clinical Trial, Xiangya Hospital, Central South University, Changsha, Hunan, P. R. China.
Central South University · CNSun Yat-sen University · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo explore a method for evaluating the bioequivalence of acarbose based on pharmacodynamic parameters using a single-dose, randomized-sequence, three-way crossover study of acarbose test (T) and reference (R) formulations.

methodsBaseline-adjusted, pre-dose value deduction, and direct comparison methods were used to evaluate the geometric T/R ratios and 90% confidence intervals (CIs) of the ln-transformed pharmacodynamic parameters to identify the most suitable evaluation system. Twelve participants were randomly divided into three groups to receive treatment in the following sequences: TRR, RTR, and RRT, each including a 7-day washout period between treatment periods. The serum glucose concentration (baseline) was determined. Pharmacodynamic parameters, including the maximum reduction in serum glucose concentrations (ΔC

resultsUsing the direct comparison method, the geometric mean ratios of C

conclusionsPre-dose value deduction and direct comparison methods can be initially considered suitable for assessing acarbose bioequivalence.

Indexed as

AcarboseAdministration, OralArea Under CurveCross-Over StudiesHumansTabletsTherapeutic EquivalencyAcarboseTabletsAcarbosebioequivalencecrossover studyevaluation methodpharmacodynamicspharmacokineticsvariability

Identifiers

PMID33044102
PMCPMC7556174
OpenAlexW3092290050

What Socratic holds

Textmetadata
LicenceCC BY-NC
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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.