Evidence mapPaperPMID 36897521Full record

Trial reportAdvances in therapy2023

A Bioequivalence Study of Ezetimibe/Rosuvastatin Fixed Dose Combination (10 mg/10 mg) Versus the Individual Formulations Taken Concomitantly.

Yujing Di, Zhaojun Wang, Chuandong Jia, Xin Xie, Shanshan Yang, Wenhua Wang, Xiaochuan Xie, Qian Wang, Chanyan Hu, Fang Xie and 5 more

Open access · hybridAbstract readRandomized Controlled TrialClinical Trial, Phase I
In one paragraph

Trial report in Advances in therapy, 2023. 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
1.0field-weighted citation impact, top 26% 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

1 citing paper in PubMed, 3 citations in OpenAlex.

  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

15 authors at 3 institutions in 2 countries.

Yujing DiDepartment of Medical Affairs, Phase I Center, Peking University (PKU) Care, Luzhong Hospital, No. 65, Taigong Road, Linzi District, Zibo, Shandong, China.
Zhaojun WangDepartment of Medical Affairs, Phase I Center, Peking University (PKU) Care, Luzhong Hospital, No. 65, Taigong Road, Linzi District, Zibo, Shandong, China.
Chuandong JiaDepartment of Medical Affairs, Phase I Center, Peking University (PKU) Care, Luzhong Hospital, No. 65, Taigong Road, Linzi District, Zibo, Shandong, China.
Xin XieDepartment of Medical Affairs, Phase I Center, Peking University (PKU) Care, Luzhong Hospital, No. 65, Taigong Road, Linzi District, Zibo, Shandong, China.
Shanshan YangDepartment of Medical Affairs, Phase I Center, Peking University (PKU) Care, Luzhong Hospital, No. 65, Taigong Road, Linzi District, Zibo, Shandong, China.
Wenhua WangDepartment of Medical Affairs, Phase I Center, Peking University (PKU) Care, Luzhong Hospital, No. 65, Taigong Road, Linzi District, Zibo, Shandong, China.
Xiaochuan XieDepartment of Medical Affairs, Sanofi, Beijing, China.
Qian WangDepartment of Medical Affairs, Sanofi, Shanghai, China.
Chanyan HuDepartment of Medical Affairs, Sanofi, Shanghai, China.
Fang XieDepartment of Medical Affairs, Sanofi, Shanghai, China.
Mohamed Abdel-MoneimDepartment of Medical Affairs, Sanofi, Dubai, United Arab Emirates.
Lionel HovsepianDepartment of Medical Affairs, Sanofi, Paris, France.
Yanzhen WuDepartment of Research and Development (R&D), Sanofi, Beijing, China.
Na YangDepartment of Research and Development (R&D), Sanofi, Beijing, China.
Jie HouDepartment of Medical Affairs, Phase I Center, Peking University (PKU) Care, Luzhong Hospital, No. 65, Taigong Road, Linzi District, Zibo, Shandong, China. jie.hou@gohealtharo.com.
Peking University · CNSanofi (China) · CNSanofi (France) · FR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionThis study evaluated the bioequivalence of ezetimibe/rosuvastatin fixed dose combination compared to the concomitant administration of individual formulations (ezetimibe and rosuvastatin) in Chinese healthy subjects under fasting conditions.

methodsThis was a phase I, randomized, open-label, two-treatment, two-period, two-sequence, crossover study conducted in healthy Chinese participants under fasting conditions. C

resultsOf the 68 subjects enrolled, 67 were treated. Systemic exposure to rosuvastatin based on C

conclusionsFixed dose combination of ezetimibe/rosuvastatin (10 mg/10 mg) achieved bioequivalence with reference to commercial tablets. TRIAL REGISTRATION NUMBER: CTR20202108.

Indexed as

Rosuvastatin CalciumArea Under CurveCross-Over StudiesEzetimibeHumansTabletsTherapeutic EquivalencyEzetimibeRosuvastatin CalciumTabletsBioequivalenceEzetimibeFixed-dose combinationPharmacokineticsRosuvastatin

Identifiers

PMID36897521
PMCPMC10129950
OpenAlexW4323811079

What Socratic 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 Socratic graph.