Evidence map›Paper›PMID 39478967›Full record

ArticleFrontiers in pharmacology2024

Pharmacokinetics and bioequivalence of two formulations of mifepristone tablets in healthy Chinese subjects under fasting conditions: a single-center, open, randomized, single-dose, double-period, two-sequence, crossover trial.

Yufeng Yan, Xiaoshan Zhu, Ping Dong, Cheng Liu, Lingqing Lu, Liyan Zeng, Guiying Chen, Xianmin Meng, Min Liu

Abstract read
In one paragraph

Article in Frontiers in pharmacology, 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
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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

9 authors.

Yufeng YanDepartment of Pharmacy, Shanghai Public Health Clinical Center, Fudan University, Shanghai, China.
Xiaoshan ZhuWuhan Jiulong Humanwell Pharmaceutical Co., Ltd., Wuhan, China.
Ping DongDepartment of Pharmacy, Shanghai Public Health Clinical Center, Fudan University, Shanghai, China.
Cheng LiuWuhan Jiulong Humanwell Pharmaceutical Co., Ltd., Wuhan, China.
Lingqing LuOffice of Drug Clinical Trials Institution, Shanghai Public Health Clinical Center, Fudan University, Shanghai, China.
Liyan ZengDepartment of Clinical Research, Shanghai Public Health Clinical Center, Fudan University, Shanghai, China.
Guiying ChenWuhan Hongren Biopharmaceutical Inc., Wuhan, China.
Xianmin MengDepartment of Pharmacy, Shanghai Public Health Clinical Center, Fudan University, Shanghai, China.
Min LiuGynaecology and Obstetrics, Shanghai Public Health Clinical Center, Fudan University, Shanghai, China.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Objective: A bioequivalence (BE) study was performed to evaluate the pharmacokinetics, safety, and bioequivalence of two formulations of mifepristone tablets in healthy Chinese volunteers under fasting conditions. Methods: A single-center, open, randomized, single-dose, double-period, two-sequence, crossover study in healthy subjects under fasting conditions was performed. The subjects received a single fasting dose of mifepristone (10 mg/tablet) during the first and second periods, followed by a 14-day washout period, during which frequent pharmacokinetic (PK) sampling occurred up to 120 h. The pharmacokinetic parameters of mifepristone were calculated based on the plasma drug concentration-time profile. Primary endpoints were the BE of major pharmacokinetic parameters (AUC Results: Forty subjects (34 male and 6 female subjects) were randomly assigned to treatment, with 39 completing the two-period study. After the single administration of mifepristone tablets (test preparation vs. reference preparation) under fasting conditions, the geometric mean ratios (GMRs) of C Conclusion: The PK parameters of mifepristone and its metabolites (RU42633 and RU42698) were measured using the (GMRs) of AUC Clinical Trial Registration: chinadrugtrials.org.cn, identifier CTR20182413.

Indexed as

bioequivalencefasting conditionhealthy Chinese subjectsmifepristonepharmacokinetic

Identifiers

PMID39478967
PMCPMC11522854

What Socratic holds

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LicenceCC BY
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Registered trials

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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.