Evidence map›Paper›PMID 38703321›Full record

Trial reportCancer chemotherapy and pharmacology2024

Effect of food on the pharmacokinetics and safety profiles of a new PARP inhibitor fuzuloparib capsules in healthy volunteers.

Pengfei Du, Yao Long, Minhui Wang, Yunzhe Huang, Yaqin Wang, Xinyan Chen, Yuhong Lin, Jianbang Wu, Jie Shen, Yuanwei Jia

Abstract readRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Cancer chemotherapy and pharmacology, 2024. 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. Article
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

10 authors.

Pengfei Du *School of Pharmacy, Wannan Medical College, Wuhu, Anhui, People's Republic of China.
Yao Long *School of Pharmacy, Wannan Medical College, Wuhu, Anhui, People's Republic of China.
Minhui WangAnhui Provincial Center of Drug Clinical Evaluation, The First Affiliated Hospital of Wannan Medical College (Yijishan Hospital of Wannan Medical College), Wuhu, Anhui, People's Republic of China.
Yunzhe HuangSchool of Pharmacy, Wannan Medical College, Wuhu, Anhui, People's Republic of China.
Yaqin WangAnhui Provincial Center of Drug Clinical Evaluation, The First Affiliated Hospital of Wannan Medical College (Yijishan Hospital of Wannan Medical College), Wuhu, Anhui, People's Republic of China.
Xinyan ChenSchool of Pharmacy, Wannan Medical College, Wuhu, Anhui, People's Republic of China.
Yuhong LinSchool of Pharmacy, Wannan Medical College, Wuhu, Anhui, People's Republic of China.
Jianbang WuSchool of Pharmacy, Wannan Medical College, Wuhu, Anhui, People's Republic of China.
Jie ShenSchool of Pharmacy, Wannan Medical College, Wuhu, Anhui, People's Republic of China. 5845438@qq.com.
Yuanwei JiaAnhui Provincial Center of Drug Clinical Evaluation, The First Affiliated Hospital of Wannan Medical College (Yijishan Hospital of Wannan Medical College), Wuhu, Anhui, People's Republic of China. 65227734@qq.com.

Funding

"Climbing Peak" Training Program for Innovation Technology team of Yijishan Hospital, Wannan Medical College KPF2019016"Peak" Training Program for Scientific Research of Yijishan Hospital, Wannan Medical College GF2019J05; GF2019J06Special Foundation for Talents of Yijishan Hospital YR201913; YR202015
6 · The paper itself

Abstract

purposeThis study assessed effect of food on pharmacokinetics (PK) and safety of fuzuloparib capsules.

methodsA randomized, open-label, two-cycle, two-sequence, crossover clinical trial was conducted. 20 subjects were randomly assigned to 2 groups at a 1:1 ratio. The first group subjects were orally administered 150 mg fuzuloparib capsules under fasting condition in first dosing cycle. The same dose of fuzuloparib capsules were taken under postprandial state after a 7-day washout period. The second group was reversed. 3 ml whole blood was collected at each blood collection point until 72 h post dose. PK parameters were calculated. Furthermore, safety assessment was performed.

resultsThe time to maximum concentration (T

conclusionFood decreased the absorption rate and slowed time to peak exposure of fuzuloparib capsules, without impact on absorption extent. Dosing with food was found to be safe for fuzuloparib capsules in this study. CLINICAL

trial registrationThis study was registered with chinadrugtrials.org.cn (identifier: CTR20221498).

Indexed as

CapsulesCross-Over StudiesFood-Drug InteractionsHealthy VolunteersPoly(ADP-ribose) Polymerase InhibitorsAdministration, OralAdultArea Under CurveFastingFemaleHumansMaleMiddle AgedYoung AdultCapsulesPoly(ADP-ribose) Polymerase InhibitorsFood effectFuzuloparibPARP inhibitorsPharmacokineticsSafety

Identifiers

What OpenQuestion holds

Textmetadata
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.