Evidence map›Paper›PMID 42823777›Full record

Trial reportBMC pharmacology & toxicology2026

Pharmacokinetic and bioequivalence evaluation of teneligliptin hydrobromide tablets following single-dose administration in healthy Chinese volunteers under fasting and fed conditions.

Zhaofeng Guan, Mingqi Chen, Biying Wei, Jianfen Su, Dongmei Tan, Jiefeng Ke, Guoping Huang

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in BMC pharmacology & toxicology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

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

0 citing papers in PubMed.

No citing paper in PubMed yet.

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.

Zhaofeng GuanDepartment of Pharmacy, The Affiliated Panyu Central Hospital, Guangzhou Medical University, Guangzhou, China.
Mingqi ChenDepartment of Pharmacy, The Affiliated Panyu Central Hospital, Guangzhou Medical University, Guangzhou, China.
Biying WeiDepartment of Pharmacy, The Affiliated Panyu Central Hospital, Guangzhou Medical University, Guangzhou, China.
Jianfen SuDepartment of Pharmacy, The Affiliated Panyu Central Hospital, Guangzhou Medical University, Guangzhou, China.
Dongmei TanDepartment of Pharmacy, The Affiliated Panyu Central Hospital, Guangzhou Medical University, Guangzhou, China.
Jiefeng KeDepartment of Pharmacy, The Affiliated Panyu Central Hospital, Guangzhou Medical University, Guangzhou, China.
Guoping HuangDepartment of Medical Equipment, The Affiliated Panyu Central Hospital, Guangzhou Medical University, Guangzhou, China. huangguoping@pyhospital.com.cn.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundBy inhibiting dipeptidyl peptidase-4 (DPP-4), teneligliptin provides a therapeutic option for type 2 diabetes mellitus (T2DM) that is widely used in Asia. A generic product could lessen treatment costs, provided that its systemic availability is equivalent to that of the branded formulation. Such comparative information remains scarce for Chinese recipients of teneligliptin hydrobromide. We therefore investigated a new generic tablet as the test product and Tenelia

methodsA total of 52 healthy Chinese adults participated in a randomized, open-label crossover investigation involving one dose, two sequences, and two periods; 26 participants were assigned to each sequence. The test and reference products were each administered at 40 mg in the fasting and fed studies, and administrations were 7 days apart. A validated LC-MS/MS assay yielded plasma teneligliptin concentrations. After logarithmic transformation, AUC

resultsIn each dietary setting, the two products produced similar teneligliptin exposure. For AUC

conclusionWhether administered in the fasting or fed state, the generic tablet met the regulatory requirements for bioequivalence with Tenelia

trial registrationThe study was registered retrospectively in the Chinese Clinical Trial Registry (ChiCTR2500112749; November 19, 2025). Ethical approval was obtained from the Ethics Committee of The Affiliated Panyu Central Hospital, Guangzhou Medical University (PYZXYYEC [2025-013 (YW)]-01).

Indexed as

Dipeptidyl-Peptidase IV InhibitorsDrugs, GenericPyrazolesThiazolidinesAdultArea Under CurveAsian PeopleCross-Over StudiesEast Asian PeopleFastingFemaleHealthy VolunteersHumansMaleMiddle AgedPiperazines3-(4-(4-(3-methyl-1-phenyl-1H-pyrazol-5-yl)piperazin-1-yl)pyrrolidin-2-ylcarbonyl)thiazolidine4-(3-amino-4-(2,4,5-trifluorophenyl)butanoyl)-3-(tert-butoxymethyl)piperazin-2-oneDipeptidyl-Peptidase IV InhibitorsDrugs, GenericPiperazinesPyrazolesTabletsThiazolidinesBioequivalencePharmacokineticsSafetyTeneligliptin hydrobromideType 2 diabetes mellitus

Identifiers

PMID42823777
PMCPMC13632194

What Socratic holds

Textmetadata
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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.