Evidence map›Paper›PMID 36369609›Full record

Trial reportDrugs in R&D2022

Pharmacokinetics, Bioequivalence and Safety of Cloperastine in Chinese Healthy Subjects Under Fasting and Postprandial Conditions.

Hong-Yu Luo, Hui-Zhi Long, Zi-Wei Zhou, Shuo-Guo Xu, Feng-Jiao Li, Yan Cheng, Dan-Dan Wen, Ping Deng, Li-Chen Gao

Open access · goldAbstract readRandomized Controlled TrialClinical Trial, Phase I
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Drugs in R&D, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
0.5field-weighted citation impact, top 34% 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

3 citing papers in PubMed, 4 citations in OpenAlex.

  1. Review
  2. Article
  3. 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 1 institution in 1 country.

Hong-Yu LuoSchool of Pharmacy, Department of Pharmacy, Phase I Clinical Trial Centre, Changsha Central Hospital Affiliated to University of South China, University of South China, Hengyang, China.ORCID http://orcid.org/0000-0003-3357-9154
Hui-Zhi LongSchool of Pharmacy, Department of Pharmacy, Phase I Clinical Trial Centre, Changsha Central Hospital Affiliated to University of South China, University of South China, Hengyang, China.
Zi-Wei ZhouSchool of Pharmacy, Department of Pharmacy, Phase I Clinical Trial Centre, Changsha Central Hospital Affiliated to University of South China, University of South China, Hengyang, China.
Shuo-Guo XuSchool of Pharmacy, Department of Pharmacy, Phase I Clinical Trial Centre, Changsha Central Hospital Affiliated to University of South China, University of South China, Hengyang, China.
Feng-Jiao LiSchool of Pharmacy, Department of Pharmacy, Phase I Clinical Trial Centre, Changsha Central Hospital Affiliated to University of South China, University of South China, Hengyang, China.
Yan ChengSchool of Pharmacy, Department of Pharmacy, Phase I Clinical Trial Centre, Changsha Central Hospital Affiliated to University of South China, University of South China, Hengyang, China.
Dan-Dan WenSchool of Pharmacy, Department of Pharmacy, Phase I Clinical Trial Centre, Changsha Central Hospital Affiliated to University of South China, University of South China, Hengyang, China.
Ping DengSchool of Pharmacy, Department of Pharmacy, Phase I Clinical Trial Centre, Changsha Central Hospital Affiliated to University of South China, University of South China, Hengyang, China.
Li-Chen GaoSchool of Pharmacy, Department of Pharmacy, Phase I Clinical Trial Centre, Changsha Central Hospital Affiliated to University of South China, University of South China, Hengyang, China. 89206346@qq.com.
Changsha Central Hospital · CN

Funding

Changsha Central Hospital Affiliated to University of South China Foundation of key Program YNKY202205Hunan Province Foundation of High-level Health Talent 225 ProgramNatural Science Foundation of Hunan Province 2021JJ30753Science and Technology Key Program of Hunan Province Grants 2016SK2066Science and Technology Key Program of Hunan Provincial Health Committee 20201904Wellcome Trust 201940
6 · The paper itself

Abstract

backgroundCloperastine is a pivotal antibechic widely prescribed to treat cough caused by respiratory diseases. The present trial evaluated the pharmacokinetics (PK), bioequivalence (BE) and safety effects of the generic test (T) tablet of cloperastine after single-dose administration of cloperastine, compared with the original reference (R) tablet of cloperastine.

objectiveThe purpose of this trial was to compare the PK, BE and safety of a test 10 mg versus the reference 10 mg formulation of cloperastine under fasting and postprandial conditions in healthy Chinese volunteers.

methodsA single-centre, randomised, open, double-cycle, self-crossover, single oral administration Phase I trial was performed in healthy Chinese volunteers. A total of 60 subjects were enrolled in either the fasting (28 subjects) or the postprandial condition (32 subjects). Subjects randomly received a single dose of the T or R preparation (10 mg dose). Plasma concentrations of cloperastine were analysed by a validated LC-MS/MS method. The primary endpoints of the PK parameters were the area under the plasma concentration-time curve from zero to 72 h (AUC

resultsA total of 25 and 30 subjects in the fasting and postprandial conditions completed this clinical trial, respectively. The geometric mean ratio (GMR) of the T/R for the C

conclusionsThe T and R preparations were bioequivalent under both conditions. Food has no significant effect on the absorption of cloperastine. Moreover, T and R preparations were well tolerated. The trial registration number (TRN) and date of registrations were CTR20212515, 13 October 2021.

Indexed as

FastingTandem Mass SpectrometryChinaChromatography, LiquidHealthy VolunteersHumansPiperidinesTabletsTherapeutic EquivalencycloperastinePiperidinesTablets

Identifiers

PMID36369609
PMCPMC9651896
OpenAlexW4308932948

What OpenQuestion holds

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LicenceCC BY-NC
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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.