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<p>This study aimed to explore the bioequivalence and safety of the fixed-dose combination (FDC) of Rosuvastatin Calcium and Ezetimibe Tablets (10/10&#xa0;mg) and loose-dose combination (LDC) formulation (rosuvastatin 10&#xa0;mg + ezetimibe 10&#xa0;mg) in healthy Chinese subjects under fasting or fed state. This was a randomized, open-label, two-period, two-crossover clinical study. The primary pharmacokinetic endpoints, including maximum plasma concentration (C<sub>max</sub>), area under the plasma concentration–time curve to the last sampling time (AUC<sub>0-t</sub>) and infinity (AUC<sub>0-inf</sub>), were used to assess the bioequivalence. A total of 476 subjects were included in bioequivalence and safety analyses. The C<sub>max</sub>, AUC<sub>0-t</sub>, and AUC<sub>0-inf</sub> for free ezetimibe, total ezetimibe, and rosuvastatin met bioequivalence criteria, with all 90% confidence intervals of geometric least squares mean (GLSM) ratios falling within the predefined range of 80.00%–125.00% under both fasting and fed states. Safety profiles were comparable between subjects receiving FDC and LDC under fasting or fed state. FDC of Rosuvastatin Calcium and Ezetimibe Tablets is bioequivalent to LDC with comparable safety profiles in healthy Chinese subjects, regardless of the feeding state.</p>

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Bioequivalence and safety of fixed-dose combination of rosuvastatin calcium and ezetimibe tablets versus coadministration of individual drugs in healthy Chinese subjects under fasting or fed state

  • 期刊论文

  • 发表日期：

    2025年7月28日

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  • Lei Gao,
  • Yue Hu,
  • Dandan Wu,
  • Wenbo Zheng,
  • Hong Zhang

摘要

This study aimed to explore the bioequivalence and safety of the fixed-dose combination (FDC) of Rosuvastatin Calcium and Ezetimibe Tablets (10/10 mg) and loose-dose combination (LDC) formulation (rosuvastatin 10 mg + ezetimibe 10 mg) in healthy Chinese subjects under fasting or fed state. This was a randomized, open-label, two-period, two-crossover clinical study. The primary pharmacokinetic endpoints, including maximum plasma concentration (Cmax), area under the plasma concentration–time curve to the last sampling time (AUC0-t) and infinity (AUC0-inf), were used to assess the bioequivalence. A total of 476 subjects were included in bioequivalence and safety analyses. The Cmax, AUC0-t, and AUC0-inf for free ezetimibe, total ezetimibe, and rosuvastatin met bioequivalence criteria, with all 90% confidence intervals of geometric least squares mean (GLSM) ratios falling within the predefined range of 80.00%–125.00% under both fasting and fed states. Safety profiles were comparable between subjects receiving FDC and LDC under fasting or fed state. FDC of Rosuvastatin Calcium and Ezetimibe Tablets is bioequivalent to LDC with comparable safety profiles in healthy Chinese subjects, regardless of the feeding state.