Evidence map›Paper›PMID 42910839›Full record

Trial reportClinical pharmacology in drug development2026

A Bioequivalence Study of Two Formulations of Enzalutamide Soft Capsules in Healthy Chinese Male Subjects.

Jianxin Wang, Kai Gu, Mingxuan Zhang, Miao Yu, Pei Zhao, Jing Yu, Xiaohong Guo, Yating Bai, Jie Liu, Xiaoli Wang and 1 more

Abstract readRandomized Controlled TrialComparative Study
In one paragraph

Trial report in Clinical pharmacology in drug development, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing 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

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

11 authors.

Jianxin WangSchool of pharmacy, Ningxia Medical University, Yinchuan, Ningxia Hui Autonomous Region, China.
Kai GuSchool of pharmacy, Ningxia Medical University, Yinchuan, Ningxia Hui Autonomous Region, China.
Mingxuan ZhangFaculty of Health Sciences (FHS), University of Macau, Taipa, Macau SAR, China.
Miao YuDepartment of Pharmacy, Gansu Provincial People's Hospital, Lanzhou, Gansu Province, China.
Pei ZhaoDepartment of Pharmacy, Gansu Provincial People's Hospital, Lanzhou, Gansu Province, China.
Jing YuDepartment of Pharmacy, Gansu Provincial People's Hospital, Lanzhou, Gansu Province, China.
Xiaohong GuoDepartment of Pharmacy, Gansu Provincial People's Hospital, Lanzhou, Gansu Province, China.
Yating BaiDepartment of Pharmacy, Gansu Provincial People's Hospital, Lanzhou, Gansu Province, China.
Jie LiuDepartment of Pharmacy, Gansu Provincial People's Hospital, Lanzhou, Gansu Province, China.
Xiaoli WangDepartment of Pharmacy, Gansu Provincial People's Hospital, Lanzhou, Gansu Province, China.
Xiaolai YangSchool of pharmacy, Ningxia Medical University, Yinchuan, Ningxia Hui Autonomous Region, China.

Funding

Practice and Research on the Construction of a Technical Platform for New Drug Clinical Evaluation 2023GSMPA047Shandong New Time Pharmaceutical Co., Ltd.
6 · The paper itself

Abstract

Enzalutamide is an oral second-generation androgen receptor inhibitor used for advanced prostate cancer. This study evaluated the pharmacokinetics (PK), bioequivalence (BE), and safety of a newly developed generic enzalutamide soft capsule (test) compared with the reference product (XTANDI) in healthy Chinese adults under fasting and fed conditions. A single-center, randomized, open-label, two-period, two-sequence, crossover study was conducted in 72 male participants (36 fasting and 36 fed). Each participant received a single 40-mg dose of test or reference formulation, separated by a 34-day washout. Blood samples were collected up to 72 h post-dose. PK parameters (C

Indexed as

Drugs, GenericPhenylthiohydantoinAdministration, OralAdultArea Under CurveAsian PeopleBenzamidesCapsulesChinaCross-Over StudiesEast Asian PeopleFastingHealthy VolunteersHumansMaleMiddle AgedBenzamidesCapsulesDrugs, GenericenzalutamideNitrilesPhenylthiohydantoinbioequivalenceenzalutamide soft capsulespharmacokineticssafety

Identifiers

PMID42910839
PMCPMC13689526

What OpenQuestion holds

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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.