Evidence map›Paper›PMID 30643391›Full record

Trial reportDrug design, development and therapy2019

Bioequivalence of two quetiapine extended release tablets in Chinese healthy volunteers under fasting and fed conditions and effects of food on pharmacokinetic profiles.

Xiaomei Huang, Suhua Zhang, Yanxia Ma, Heng Yang, Chuan He, Rufang Tian, Han Mei, Lipeng Liu, Bikui Zhang

Open access · goldAbstract readEquivalence TrialRandomized Controlled Trial
In one paragraph

Trial report in Drug design, development and therapy, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
1.2field-weighted citation impact, top 21% 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.

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

5 citing papers in PubMed, 8 citations in OpenAlex.

  1. Article
  2. Review
  3. Review
  4. Article
  5. Review
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 at 2 institutions in 2 countries.

Xiaomei HuangDepartment of National Drug Clinical Trial Research Center, Xiangya Boai Rehabilitation Hospital, Changsha, People's Republic of China, 505995@csu.edu.cn; llp686@126.com.
Suhua ZhangDepartment of Pharmacy, The Second Xiangya Hospital of Central South University, Changsha, People's Republic of China, 505995@csu.edu.cn.
Yanxia MaDepartment of National Drug Clinical Trial Research Center, Xiangya Boai Rehabilitation Hospital, Changsha, People's Republic of China, 505995@csu.edu.cn; llp686@126.com.
Heng YangDepartment of National Drug Clinical Trial Research Center, Xiangya Boai Rehabilitation Hospital, Changsha, People's Republic of China, 505995@csu.edu.cn; llp686@126.com.
Chuan HeDepartment of National Drug Clinical Trial Research Center, Xiangya Boai Rehabilitation Hospital, Changsha, People's Republic of China, 505995@csu.edu.cn; llp686@126.com.
Rufang TianDepartment of National Drug Clinical Trial Research Center, Xiangya Boai Rehabilitation Hospital, Changsha, People's Republic of China, 505995@csu.edu.cn; llp686@126.com.
Han MeiDepartment of National Drug Clinical Trial Research Center, Xiangya Boai Rehabilitation Hospital, Changsha, People's Republic of China, 505995@csu.edu.cn; llp686@126.com.
Lipeng LiuDepartment of National Drug Clinical Trial Research Center, Xiangya Boai Rehabilitation Hospital, Changsha, People's Republic of China, 505995@csu.edu.cn; llp686@126.com.
Bikui ZhangDepartment of National Drug Clinical Trial Research Center, Xiangya Boai Rehabilitation Hospital, Changsha, People's Republic of China, 505995@csu.edu.cn; llp686@126.com.
National Clinical Research · USCentral South University · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveThe objectives of this study were to evaluate the bioequivalence of Quesero extended release (Quesero XR) tablets and Seroquel extended release (Seroquel XR) tablets under fasting and fed conditions and to determine the effect of food on the pharmacokinetic (PK) properties of Quesero XR or Seroquel XR in Chinese healthy volunteers.

methodsA single-site, randomized, open-label, two-period crossover design with a 10-day washout period was conducted in 20 subjects under the fed and fasting studies. A single oral dose of 200 mg Quesero XR or Seroquel XR was given to the subjects after an overnight fast of 10 hours. Blood samples were taken at scheduled time spots from 0 hour pre dose to 36 hours post dose. Plasma concentrations of quetiapine were measured by a validated ultra-performance liquid chromatography-tandem mass spectrometry (UPLC-MS/MS) method. The PK parameters were calculated by non-compartment analysis using Phoenix WinNonlin software.

resultsOn both conditions, no significant differences were found among the main PK parameters of the two preparations by analysis of variance (

conclusionThe two formulations of Quesero XR and Seroquel XR are bioequivalent under both fasting and fed conditions, and food may affect the PK profiles by increasing the rate and extent of absorption of Quesero XR or Seroquel XR in Chinese healthy volunteers.

Indexed as

Food-Drug InteractionsAdministration, OralAdolescentAdultChromatography, High Pressure LiquidCross-Over StudiesDose-Response Relationship, DrugFastingFemaleHealthy VolunteersHumansMaleQuetiapine FumarateTabletsTandem Mass SpectrometryTherapeutic EquivalencyQuetiapine FumarateTabletsfood effectpharmacokineticsquetiapineUPLC-MS/MS

Identifiers

PMID30643391
PMCPMC6319427
OpenAlexW2907762535

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

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.