Trial reportDrugs in R&D2024
Bioequivalence Study of Tebipenem Pivoxil in Healthy Chinese Adults.
Rui Hao, Yiming Shao, Sisi Lin, Yi Wu, Li Bian, Yiwen Zhang
Open access · goldAbstract readRandomized Controlled Trial
In one paragraphTrial report in Drugs in R&D, 2024. 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, top 97% of its field
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 registryThe 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 literatureWho cites it
0 citing papers in PubMed, 0 citations in OpenAlex.
No citing paper in PubMed yet.
4 · The recordCorrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
5 · Who and what moneyAuthors and funding
6 authors at 3 institutions in 1 country.
Rui HaoCenter for Clinical Pharmacy, Cancer Center, Department of Pharmacy, Zhejiang Provincial People's Hospital (Affiliated People's Hospital), Hangzhou Medical College, No. 158 Shangtang Road, Gongshu District, Hangzhou, 310014, Zhejiang, China.ORCID http://orcid.org/0000-0002-9700-1434 Yiming ShaoCenter for Clinical Pharmacy, Cancer Center, Department of Pharmacy, Zhejiang Provincial People's Hospital (Affiliated People's Hospital), Hangzhou Medical College, No. 158 Shangtang Road, Gongshu District, Hangzhou, 310014, Zhejiang, China.
Sisi LinCenter for Clinical Pharmacy, Cancer Center, Department of Pharmacy, Zhejiang Provincial People's Hospital (Affiliated People's Hospital), Hangzhou Medical College, No. 158 Shangtang Road, Gongshu District, Hangzhou, 310014, Zhejiang, China.
Yi WuCenter for Clinical Pharmacy, Cancer Center, Department of Pharmacy, Zhejiang Provincial People's Hospital (Affiliated People's Hospital), Hangzhou Medical College, No. 158 Shangtang Road, Gongshu District, Hangzhou, 310014, Zhejiang, China.
Li BianInner Mongolia Tongliao Market Inspection and Testing Center, Tongliao, China.
Yiwen ZhangCenter for Clinical Pharmacy, Cancer Center, Department of Pharmacy, Zhejiang Provincial People's Hospital (Affiliated People's Hospital), Hangzhou Medical College, No. 158 Shangtang Road, Gongshu District, Hangzhou, 310014, Zhejiang, China. zjzyw2003@163.com.
Zhejiang Provincial People's Hospital · CNHangzhou Medical College · CNTongliao Academy of Agricultural Sciences · CN
Funding
Zhejiang Provincial Program for the Cultivation of New Heath Talents (to Yiwen Zhang), Zhejiang Provincial TCM Science and Technology Plan Project (2021ZZ001 and 2022ZB017), the Medical Science and Technology Project of Zhejiang Provincial (2021KY040 and 2021KY040Zhejiang Provincial Program for the Cultivation of New Heath Talents (to Yiwen Zhang), Zhejiang Provincial TCM Science and Technology Plan Project (2021ZZ001 and 2022ZB017), the Medical Science and Technology Project of Zhejiang Provincial (2021KY040 and 2021ZZ001Zhejiang Provincial Program for the Cultivation of New Heath Talents (to Yiwen Zhang), Zhejiang Provincial TCM Science and Technology Plan Project (2021ZZ001 and 2022ZB017), the Medical Science and Technology Project of Zhejiang Provincial (2021KY040 and 2022KY069Zhejiang Provincial Program for the Cultivation of New Heath Talents (to Yiwen Zhang), Zhejiang Provincial TCM Science and Technology Plan Project (2021ZZ001 and 2022ZB017), the Medical Science and Technology Project of Zhejiang Provincial (2021KY040 and 2022ZB017
6 · The paper itselfAbstract
BACKGROUND AND
objectiveTebipenem pivoxil (TP) is a carbapenem and is applied against pneumonia, otitis media, and sinusitis. This study compared the pharmacokinetics (PK) and safety of a test (T) preparation and reference (R) preparation of TP in healthy Chinese adults.
methodsThis study was a single-center, randomized, open, single-dose (fasting/postprandial) oral administration, two-agent, two-sequence, two-cycle, crossover bioequivalence trial. A total of 60 participants were enrolled (24 fasting and 36 postprandial). All participants were randomly assigned to the TR sequence and RT sequence. Subsequently, they switched T sequences or R sequences 7 days later. PK blood samples were collected according to the protocol, plasma TP concentration was determined by liquid chromatography-mass spectrometry, main PK parameters were calculated based on a non-compartment model, and adverse events were recorded during the test.
resultsIn the feeding arm, the geometric mean ratio of maximum concentration (C
conclusionPreparations T and R of TP were bioequivalent in the fasting and postprandial groups in clinical trials, and TP was safe.
Indexed as
Anti-Bacterial AgentsCarbapenemsAdministration, OralAdultArea Under CurveChinaCross-Over StudiesEast Asian PeopleFastingFemaleHealthy VolunteersHumansMaleMiddle AgedTherapeutic EquivalencyYoung AdultAnti-Bacterial AgentsCarbapenemstebipenem
Identifiers
PMID38451449
PMCPMC11035523
OpenAlexW4392559882
What OpenQuestion holds
Textmetadata
LicenceCC BY-NC
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