Evidence map›Paper›PMID 35794358›Full record

Trial reportClinical pharmacology in drug development2023

Pharmacokinetics and Bioequivalence of Fudosteine in Healthy Chinese Volunteers Under Fasting and Fed Conditions: A 4-Way Replicate Crossover Study.

Mingxue Zhu, Yi Tao, Junliang Pu, Hongtao Zhao, Lei Wan, Peilin Zhang, Chengyong Tang

Registry-linked trialOpen access · hybridAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Clinical pharmacology in drug development, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06762743 (A Randomized, Open-Label, Two-Formulation, Two-Period, Crossover Bioequivalence Study of Oral Brivaracetam Solution Administered As a Single Dose Under Fasting and High-fat Meal Conditions in Healthy Subjects), which is not on this 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 91% 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.

NCT06762743 phase1unknown statusnot on this mapstarted 2024, after this paper: background citation

A Randomized, Open-Label, Two-Formulation, Two-Period, Crossover Bioequivalence Study of Oral Brivaracetam Solution Administered As a Single Dose Under Fasting and High-fat Meal Conditions in Healthy Subjects

TypeinterventionalSponsorJiangsu Chia Tai Fenghai Pharmaceutical Co., Ltd.Ran2024 to 2024Enrolled60ConditionsEpilepsy (treatment Refractory)ArmsBrivaracetam Oral Solution (Test Formulation), Brivaracetam Oral Solution (Reference Formulation)
3 · Its place in the literature

Who cites it

0 citing papers in PubMed, 0 citations in OpenAlex.

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 at 2 institutions in 1 country.

Mingxue ZhuDepartment of Phase I Clinical Trial Ward, The First Affiliated Hospital of Chongqing Medical University, Chongqing, China.
Yi TaoDepartment of Phase I Clinical Trial Ward, The First Affiliated Hospital of Chongqing Medical University, Chongqing, China.
Junliang PuDepartment of Phase I Clinical Trial Ward, The First Affiliated Hospital of Chongqing Medical University, Chongqing, China.
Hongtao ZhaoDepartment of Phase I Clinical Trial Ward, The First Affiliated Hospital of Chongqing Medical University, Chongqing, China.
Lei WanDepartment of Phase I Clinical Trial Ward, The First Affiliated Hospital of Chongqing Medical University, Chongqing, China.
Peilin ZhangDepartment of Phase I Clinical Trial Ward, The First Affiliated Hospital of Chongqing Medical University, Chongqing, China.
Chengyong TangDepartment of Phase I Clinical Trial Ward, The First Affiliated Hospital of Chongqing Medical University, Chongqing, China.
First Affiliated Hospital of Chongqing Medical University · CNChongqing Medical University · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The bioequivalence of a generic fudosteine tablet vs a brand-named fudosteine tablet under fasting and fed conditions was evaluated in this study. This randomized, open-label, single-dose, 4-way replicate, crossover, bioequivalence study included 64 healthy Chinese subjects (fasting cohort, n = 32; fed cohort, n = 32) who were assigned to receive a single 200-mg dose of generic or brand-named fudosteine. Blood samples were collected before dosing and up to 24 hours after dosing. The plasma concentrations of fudosteine were analyzed by high-performance liquid chromatography-tandem mass spectrometry. Safety was monitored. There were no significant differences in maximum plasma concentration (C

Indexed as

East Asian PeopleFastingCross-Over StudiesCystineHealthy VolunteersHumansTabletsTherapeutic EquivalencyCystinefudosteineTabletsbioequivalencefasting and fedfudosteinehighly variable drugpharmacokinetics

Identifiers

PMID35794358
PMCPMC10084052
OpenAlexW4284882878

What OpenQuestion holds

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LicenceCC BY-NC-ND
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Registered trials

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 OpenQuestion graph.