Evidence map›Paper›PMID 41318994›Full record

Trial reportPharmacology research & perspectives2025

A Single Dose, Randomized, Open-Label, Cross-Over Bioequivalence Study of Budesonide Pressurized Metered-Dose Inhaler in Healthy Chinese Subjects.

Kai Huang, Shaohong Yin, Weiguo Huang, Lairong Ding, Wei Qin, Zhenzhong Qian, Ying Ding, Linling Que, Yunfei Shi, Jinxia Gao and 1 more

Abstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Pharmacology research & perspectives, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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

1 citing paper in PubMed.

  1. Trial
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

11 authors.

Kai HuangDrug Clinical Trial Institution, The Affiliated Wuxi People's Hospital of Nanjing Medical University, Wuxi People's Hospital, Wuxi Medical Center, Nanjing Medical University, Wuxi, China.
Shaohong YinLunan Better Pharmaceutical Co. LTD, Shandong, China.
Weiguo HuangLunan Better Pharmaceutical Co. LTD, Shandong, China.
Lairong DingLunan Better Pharmaceutical Co. LTD, Shandong, China.
Wei QinDrug Clinical Trial Institution, The Affiliated Wuxi People's Hospital of Nanjing Medical University, Wuxi People's Hospital, Wuxi Medical Center, Nanjing Medical University, Wuxi, China.
Zhenzhong QianDrug Clinical Trial Institution, The Affiliated Wuxi People's Hospital of Nanjing Medical University, Wuxi People's Hospital, Wuxi Medical Center, Nanjing Medical University, Wuxi, China.
Ying DingDrug Clinical Trial Institution, The Affiliated Wuxi People's Hospital of Nanjing Medical University, Wuxi People's Hospital, Wuxi Medical Center, Nanjing Medical University, Wuxi, China.
Linling QueDrug Clinical Trial Institution, The Affiliated Wuxi People's Hospital of Nanjing Medical University, Wuxi People's Hospital, Wuxi Medical Center, Nanjing Medical University, Wuxi, China.ORCID 0000-0003-3380-8105
Yunfei ShiDrug Clinical Trial Institution, The Affiliated Wuxi People's Hospital of Nanjing Medical University, Wuxi People's Hospital, Wuxi Medical Center, Nanjing Medical University, Wuxi, China.
Jinxia GaoLunan Better Pharmaceutical Co. LTD, Shandong, China.
Yi ZhaoDrug Clinical Trial Institution, The Affiliated Wuxi People's Hospital of Nanjing Medical University, Wuxi People's Hospital, Wuxi Medical Center, Nanjing Medical University, Wuxi, China.

Funding

Lunan Better Pharmaceutical Co., LTD
6 · The paper itself

Abstract

Budesonide is a first-line inhaled glucocorticoid (ICS) for asthma treatment in adults and children. The purpose of this study was to compare the pharmacokinetics and assess the bioequivalence between two budesonide pressurized metered-dose inhalers (pMDIs, 200 μg/actuation × 1 actuation) in healthy Chinese subjects. The study was conducted in 32 healthy Chinese subjects using a single-center, randomized, open-label, four-period and crossover design with a 3-day washout between periods. Blood samples were collected up to 16 h post-dose. Plasma concentrations of budesonide were quantified using liquid chromatography-tandem mass spectrometry (LC-MS/MS). Reference-scaled average bioequivalence (RSABE) or average bioequivalence (ABE) method was applied to evaluate the bioequivalence, on the basis of the within-subject standard deviation (S

Indexed as

BudesonideGlucocorticoidsMetered Dose InhalersAdministration, InhalationAdultArea Under CurveChinaCross-Over StudiesEast Asian PeopleFemaleHealthy VolunteersHumansMaleMiddle AgedTandem Mass SpectrometryTherapeutic EquivalencyBudesonideGlucocorticoidsbioequivalencebudesonidepharmacokineticspressurized metered dose inhaler

Identifiers

PMID41318994
PMCPMC12664903

What OpenQuestion holds

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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 OpenQuestion graph.