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Int. Journal of Clinical Pharmacology and Therapeutics, Volume 61 (2023) - March (129 - 138)

Pharmacokinetics, safety, and bioequivalence of apixaban tablets in healthy Chinese subjects under fasting and fed conditions

Hong-Yu Luo1, 2, Zhen-Jiang Yao3, Hui-Zhi Long1, 2, Zi-Wei Zhou1, 2, Shuo-Guo Xu1, 2, Feng-Jiao Li1, 2, Yan Cheng1, 2, Dan-Dan Wen1, 2, Ping Deng1, 2, Yue-Qing Guan3, Li-Chen Gao1, 2
1 School of Pharmacy, Department of Pharmacy, Phase I Clinical Trial Center, Changsha Central Hospital Affiliated to University of South China, University of South China, Hengyang, 2 Hunan Provincial Key Laboratory of Tumor Microenvironment Responsive Drug Research, Changsha, and 3 Ningbo High Tech Zone Minova Pharmaceutical Innovation Research Institute Co., Ltd., Ningbo, China

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DOI 10.5414/CP204299

Abstract

Objective:/b> To evaluate the pharmacokinetics (PK), safety, and bioequivalence of two formulations of apixaban in healthy Chinese subjects under fasting and fed conditions.
Materials and methods:<7´/b> A single-center, randomized, open, single-dose, two-period crossover PK study was carried out under fasting and fed conditions in 64 healthy subjects enrolled in either the fasting (36 subjects) or the fed (28 subjects) arms of the study. Subjects received a single oral dose of 2.5 mg apixaban tablets as test (T) or reference (R) formulation. The primary PK parameters determined were the area under the plasma concentration-time curve from zero to t and ∞ (AUC0–t and AUC0–∞) and the maximal plasma concentration (Cmax). Safety was assessed mainly from the occurrence of adverse events (AEs).
Results: A single drop-out in the fed arm of the trial was excluded from the statistical evaluation. The 90% confidence intervals (CIs) for the geometric mean ratio (GMR) for T/R using AUC0–t were 95.4 – 100.9% and 97.8 – 103.8%, and for AUC0–∞ were 95.3 – 100.6% and 98.3 – 104.3% under fasting (36 subjects) and fed (27 subjects) conditions, respectively. Similarly, the 90% CIs for Cmax were 94.6 – 103.1% and 88.8 – 102.0% under fasting (36 subjects) and the fed (27 subjects) conditions, respectively. Therefore, the 90% CIs for the T/R AUC and Cmax ratios were within the standard range for bioequivalence (80.0 – 125.0%). There were no serious adverse events (SAEs).
Conclusion: The test and reference 2.5 mg apixaban tablets were bioequivalent and both showed good tolerability and safety.

Author Details

Authors

Departments

  • 1 School of Pharmacy, Department of Pharmacy, Phase I Clinical Trial Center, Changsha Central Hospital Affiliated to University of South China, University of South China, Hengyang,
  • 2 Hunan Provincial Key Laboratory of Tumor Microenvironment Responsive Drug Research, Changsha, and
  • 3 Ningbo High Tech Zone Minova Pharmaceutical Innovation Research Institute Co., Ltd., Ningbo, China

Address

Li-Chen Gao, MD
School of Pharmacy, Department of Pharmacy
Phase I Clinical Trial Centre
Changsha Central Hospital
Affiliated to University of South China
Changsha, 410004 China
Email: [email protected]

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Citation

Hong-Yu Luo, Zhen-Jiang Yao, Hui-Zhi Long, Zi-Wei Zhou, Shuo-Guo Xu, Feng-Jiao Li, Yan Cheng, Dan-Dan Wen, Ping Deng, Yue-Qing Guan, Li-Chen Gao.Pharmacokinetics, safety, and bioequivalence of apixaban tablets in healthy Chinese subjects under fasting and fed conditions
. Int J Clin Pharmacol Ther. 2023; 61: 129-138. doi: 10.5414/CP204299. Pubmed: https://pubmed.ncbi.nlm.nih.gov/36458443/; PMID: 36458443.

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