Evidence map›Paper›PMID 42665804›Full record

Trial reportBMC pharmacology & toxicology2026

Pharmacokinetic and bioequivalence study of enteric-coated omeprazole capsule in healthy Chinese subjects under fasting and fed conditions.

Fucai Zhang, Jingyi Xie, Yong Li, Wenlu Feng, Jianfen Su, Nan Mao

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

6 authors.

Fucai Zhang *The Affiliated Panyu Central Hospital, Guangzhou Medical University, No. 8 Fuyu East Road, Panyu District, Guangzhou, 511400, China.
Jingyi Xie *The Affiliated Panyu Central Hospital, Guangzhou Medical University, No. 8 Fuyu East Road, Panyu District, Guangzhou, 511400, China.
Yong LiGuangdong Zhongsheng Pharmaceutical Co., Ltd, Dongguan, China.
Wenlu FengGuangdong Huanan Pharmaceutical Group Co., Ltd, Dongguan, China.
Jianfen SuThe Affiliated Panyu Central Hospital, Guangzhou Medical University, No. 8 Fuyu East Road, Panyu District, Guangzhou, 511400, China.
Nan MaoThe Affiliated Panyu Central Hospital, Guangzhou Medical University, No. 8 Fuyu East Road, Panyu District, Guangzhou, 511400, China. maonan@pyhospital.com.cn.

Funding

Guangdong Basic and Applied Basic Research Fund Enterprise Joint Fund 2023A1515220024Guangdong Hospital Pharmaceutical Research Fund project funding 2024A31Medical Research Foundation of Guangdong Province 2024070Research Funds from Guangzhou Panyu Central Hospital PY-2023-007, PY-2023-010, and PY-2023-026
6 · The paper itself

Abstract

purposeThis study aimed to evaluate the bioequivalence of a generic enteric-coated omeprazole capsule compared with the reference product (Losec

methodThe fasting study was conducted using a randomized, single-centre, single-dose, two-period, two-sequence crossover design. The fed study was a randomized, single-centre, single-dose, four-period, two-sequence fully replicate crossover design. Healthy subjects were randomized and received either the test or the reference drug under fasting or fed conditions. The plasma concentration of enteric-coated omeprazole capsule at different time points was measured using high-performance liquid chromatography-tandem mass spectrometry (HPLC-MS/MS). Bioequivalence of the two formulations was evaluated through pharmacokinetic parameters and relative bioavailability.

resultsIn the fasting study, the geometric mean ratios (GMRs) of C

conclusionThe two enteric-coated omeprazole capsules were bioequivalent under both fasting and fed conditions and were well tolerated in healthy subjects.

trial registrationThe trial was registered with the China Centre for Drug Testing and Registration ( http://www.chinadrugtrials.org.cn/index.html , 10/05/2022, CTR20221098 and CTR20220627).

Indexed as

OmeprazoleProton Pump InhibitorsAdultArea Under CurveCapsulesCross-Over StudiesEast Asian PeopleFastingFemaleHumansMaleTablets, Enteric-CoatedTherapeutic EquivalencyYoung AdultCapsulesOmeprazoleProton Pump InhibitorsTablets, Enteric-CoatedBioequivalenceEnteric-coated omeprazole capsulePharmacokineticsSafety

Identifiers

PMID42665804
PMCPMC13525694

What OpenQuestion holds

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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 OpenQuestion graph.