Evidence map›Paper›PMID 40859973›Full record

Trial reportDrug design, development and therapy2025

Bioequivalence Study of Palbociclib Tablets in Healthy Volunteers.

Yiting Hu, Na Zhao, Haojing Song, Jian Zhang, Lusha Bi, Bo Qiu, Yufang Xu, Caiyun Jia, Wanjun Bai

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in Drug design, development and therapy, 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. 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

9 authors.

Yiting HuDepartment of Pharmacy, Hebei General Hospital, Hebei Key Laboratory of Clinical Pharmacy, Shijiazhuang, People's Republic of China.
Na ZhaoDepartment of Pharmacy, Hebei General Hospital, Hebei Key Laboratory of Clinical Pharmacy, Shijiazhuang, People's Republic of China.
Haojing SongDepartment of Pharmacy, Hebei General Hospital, Hebei Key Laboratory of Clinical Pharmacy, Shijiazhuang, People's Republic of China.
Jian ZhangDepartment of Gastroenterology and Hepatology, Hebei General Hospital, Shijiazhuang, People's Republic of China.
Lusha BiShijiazhuang Pharmaceutical Group Ouyi Pharmaceutical Co., Ltd., Shijiazhuang, People's Republic of China.
Bo QiuDepartment of Pharmacy, Hebei General Hospital, Hebei Key Laboratory of Clinical Pharmacy, Shijiazhuang, People's Republic of China.
Yufang XuDepartment of Pharmacy, Hebei General Hospital, Hebei Key Laboratory of Clinical Pharmacy, Shijiazhuang, People's Republic of China.
Caiyun JiaDepartment of Pharmacy, Hebei General Hospital, Hebei Key Laboratory of Clinical Pharmacy, Shijiazhuang, People's Republic of China.
Wanjun BaiDepartment of Pharmacy, Hebei General Hospital, Hebei Key Laboratory of Clinical Pharmacy, Shijiazhuang, People's Republic of China.ORCID 0009-0008-3266-8765

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Objective: Bioequivalence of palbociclib tablets was evaluated in healthy volunteers under fasting and fed conditions in this study. Methods: This bioequivalence trial, which randomized subjects to receive palbociclib under fed or fasted conditions, generated these results. High-performance liquid chromatography-mass spectrometry (HPLC-MS) was employed to determine palbociclib concentrations in plasma from collected blood samples. Pharmacokinetic (PK) parameters were calculated using the non-compartmental analysis (NCA) module within Phoenix WinNonlin version 8.2. Statistical analysis of key pharmacokinetic parameters-maximum plasma concentration (C Results: The geometric mean ratios (T/R) of C Conclusion: The result indicated that the test preparation and the reference preparation of palbociclib tablets were bioequivalent under the fasted and fed conditions. The safety of the two preparations was good. Clinical Trial Registration: This trial was registered on the Chinese Clinical Trial website (http://www.chinadrugtrials.org.cn/index.html # CTR20220977).

Indexed as

PiperazinesPyridinesAdministration, OralAdultArea Under CurveChromatography, High Pressure LiquidCross-Over StudiesFastingFemaleHealthy VolunteersHumansMaleTabletsTherapeutic EquivalencyYoung AdultpalbociclibPiperazinesPyridinesTabletsbioequivalencebreast cancerpalbociclibpharmacokineticssafety

Identifiers

PMID40859973
PMCPMC12372830

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.