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<p>This study assessed the pharmacokinetics, bioequivalence, and food effect of two enteric-coated aspirin tablets (100&#xa0;mg) in healthy Chinese subjects. Ninety subjects were enrolled and divided into fasted (<i>n</i> = 42) and fed cohorts (<i>n</i> = 48) in a single-center, randomized, open-label, single-dose, four-period, two-sequence and crossover study. The pharmacokinetic characteristics of acetylsalicylic acid (aspirin) and its metabolite salicylic acid, including C<sub>max</sub> and AUC, were compared after subjects received single oral doses of enteric-coated aspirin tablet using a validated LC–MS/MS method. Bioequivalence was evaluated using the reference-scaled average bioequivalence (RSABE) approach when the within-subject standard deviation of the reference product (S<sub>WR</sub>) exceeded 0.29, while the average bioequivalence (ABE) method was applied for S<sub>WR</sub> values below 0.29. Pharmacokinetic profiles of two enteric-coated aspirin tablets were comparable after single-dose administration. The mean T<sub>max</sub>, C<sub>max</sub>, and AUC0-t were 5.5&#xa0;h, 603.97&#xa0;ng/mL and 786.47&#xa0;h·ng/mL for acetylsalicylic acid, and 6.50&#xa0;h, 4033.66&#xa0;ng/mL, and 20,115.18&#xa0;h·ng/mL for salicylic acid, respectively. Food delayed the T<sub>max</sub> and increased the C<sub>max</sub> but had no effect on the aspirin’s overall exposure. 90% CI of geometric mean ratios (GMRs) of C<sub>max</sub>, AUC<sub>0-t</sub>, and AUC<sub>0-∞</sub> of acetylsalicylic acid and salicylic acid of two enteric-coated aspirin tablets fell within the predefined bioequivalence range of 80.0–125.0% under both fasted and fed conditions. Safety assessments revealed that all treatments were safe and well tolerated. Two enteric-coated aspirin tablets were bioequivalent in Chinese healthy subjects under both fasted and fed condition. All treatments were well tolerated.</p>

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Pharmacokinetics, bioequivalence, and food effect assessment of enteric-coated aspirin tablets: a randomized, single-dose, four-period crossover study in Chinese healthy subjects

  • 期刊论文

  • 发表日期：

    2025年5月23日

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  • Minwan Hu,
  • Shuyu Zhang,
  • Peng Xu,
  • Jiangfan Li,
  • Hongxian Pang,
  • Man Yang,
  • Fangyu Chen,
  • Baoqing Gao,
  • Xuhong Wang

摘要

This study assessed the pharmacokinetics, bioequivalence, and food effect of two enteric-coated aspirin tablets (100 mg) in healthy Chinese subjects. Ninety subjects were enrolled and divided into fasted (n = 42) and fed cohorts (n = 48) in a single-center, randomized, open-label, single-dose, four-period, two-sequence and crossover study. The pharmacokinetic characteristics of acetylsalicylic acid (aspirin) and its metabolite salicylic acid, including Cmax and AUC, were compared after subjects received single oral doses of enteric-coated aspirin tablet using a validated LC–MS/MS method. Bioequivalence was evaluated using the reference-scaled average bioequivalence (RSABE) approach when the within-subject standard deviation of the reference product (SWR) exceeded 0.29, while the average bioequivalence (ABE) method was applied for SWR values below 0.29. Pharmacokinetic profiles of two enteric-coated aspirin tablets were comparable after single-dose administration. The mean Tmax, Cmax, and AUC0-t were 5.5 h, 603.97 ng/mL and 786.47 h·ng/mL for acetylsalicylic acid, and 6.50 h, 4033.66 ng/mL, and 20,115.18 h·ng/mL for salicylic acid, respectively. Food delayed the Tmax and increased the Cmax but had no effect on the aspirin’s overall exposure. 90% CI of geometric mean ratios (GMRs) of Cmax, AUC0-t, and AUC0-∞ of acetylsalicylic acid and salicylic acid of two enteric-coated aspirin tablets fell within the predefined bioequivalence range of 80.0–125.0% under both fasted and fed conditions. Safety assessments revealed that all treatments were safe and well tolerated. Two enteric-coated aspirin tablets were bioequivalent in Chinese healthy subjects under both fasted and fed condition. All treatments were well tolerated.