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Bioavailability Section

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

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, and Li-Chen Gao

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Volume 61 (2023) p. 129 - 138

Abstract

International Journal of Clinical Pharmacology and Therapeutics, Vol. 61 – No. 3/2023 (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, and Li-Chen Gao¹#²

¹School of Pharmacy, Department of Pharmacy, Phase I Clinical Trial Center, Changsha Central Hospital Affiliated to University of South China, University of South China, Hengyang, ²Hunan Provincial Key Laboratory of Tumor Microenvironment Responsive Drug Research, Changsha, and ³Ningbo High Tech Zone Minova Pharmaceutical Innovation Research Institute Co., Ltd., Ningbo, China
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 ∞ (AUC_0–t and AUC_0–∞) and the maximal plasma concentration (C_max). 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 AUC_0–t were 95.4 – 100.9% and 97.8 – 103.8%, and for AUC_0–∞ 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 C_max 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 C_max 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.Correspondence to:
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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