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Peer-reviewedCC BY-NCClinical pharmacology in drug development

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

  • Jianxin Wang1,2
  • Kai Gu1,2
  • Mingxuan Zhang3
  • Miao Yu2
  • Pei Zhao2
  • Jing Yu2
  • Xiaohong Guo2
  • Yating Bai2
  • Jie Liu2
  • Xiaoli Wang2
  • Xiaolai Yang1,2
  1. 1School of pharmacy, Ningxia Medical University, Yinchuan, Ningxia Hui Autonomous Region, China.
  2. 2Department of Pharmacy, Gansu Provincial People's Hospital, Lanzhou, Gansu Province, China.
  3. 3Faculty of Health Sciences (FHS), University of Macau, Taipa, Macau SAR, China.
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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 (Cmax and AUC0-72 h) were calculated using non-compartmental analysis. BE was assessed by 90% confidence intervals (CIs) of geometric mean ratios (GMRs). Safety was monitored throughout the study. In both fasting and fed conditions, the 90% CIs of GMRs for Cmax and AUC0-72 h were within the predefined 80%-125% BE range. Both formulations exhibited a favorable single-dose safety profile, with no serious adverse events reported. The test enzalutamide soft capsule is bioequivalent to the reference product in healthy Chinese volunteers, demonstrating similar PK profiles and safety. This study provides population-specific PK evidence supporting the clinical use of the generic formulation in China.

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Cite

BibTeXRIS
BibTeX
@article{wang2026bioequivalence,
  title = {{A Bioequivalence Study of Two Formulations of Enzalutamide Soft Capsules in Healthy Chinese Male Subjects.}},
  author = {Jianxin Wang and Kai Gu and Mingxuan Zhang and Miao Yu and Pei Zhao and Jing Yu and Xiaohong Guo and Yating Bai and Jie Liu and Xiaoli Wang and Xiaolai Yang},
  journal = {Clinical pharmacology in drug development},
  year = {2026},
  month = oct,
  doi = {10.1002/cpdd.70121},
  url = {https://europepmc.org/article/MED/42910839},
  note = {CC BY-NC},
}
RIS
TY  - JOUR
TI  - A Bioequivalence Study of Two Formulations of Enzalutamide Soft Capsules in Healthy Chinese Male Subjects.
AU  - Jianxin Wang
AU  - Kai Gu
AU  - Mingxuan Zhang
AU  - Miao Yu
AU  - Pei Zhao
AU  - Jing Yu
AU  - Xiaohong Guo
AU  - Yating Bai
AU  - Jie Liu
AU  - Xiaoli Wang
AU  - Xiaolai Yang
PY  - 2026
DA  - 2026/10/01
JO  - Clinical pharmacology in drug development
DO  - 10.1002/cpdd.70121
UR  - https://europepmc.org/article/MED/42910839
AB  - 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 (Cmax and AUC0-72 h) were calculated using non-compartmental analysis. BE was assessed by 90% confidence intervals (CIs) of geometric mean ratios (GMRs). Safety was monitored throughout the study. In both fasting and fed conditions, the 90% CIs of GMRs for Cmax and AUC0-72 h were within the predefined 80%-125% BE range. Both formulations exhibited a favorable single-dose safety profile, with no serious adverse events reported. The test enzalutamide soft capsule is bioequivalent to the reference product in healthy Chinese volunteers, demonstrating similar PK profiles and safety. This study provides population-specific PK evidence supporting the clinical use of the generic formulation in China.
SN  - 2160-763X
SN  - 2160-7648
ER  -