Nanjing Fengkaisi Pharmaceutical Research and Development Co., Ltd.

This study aimed to study the pharmacokinetic characteristics of enteric-coated aspirin tablets (100 mg) produced by Nanjing Fengkaisi Pharmaceutical Research and Development Co., Ltd. after a single oral administration after a meal; using enteric-coated aspirin tablets (100 mg) produced by Bayer HealthCare Manufacturing S.r.l. as the reference preparation, the pharmacokinetic parameters Cmax, AUC0-t, and AUC0-∞ of the two preparations were compared, and the bioequivalence of the two preparations in humans was evaluated.

This study aimed to investigate the pharmacokinetic characteristics of aspirin enteric-coated tablets (100 mg) produced by Nanjing Fengkaisi Pharmaceutical Research and Development Co., Ltd. after single fasting and postprandial oral administration; using enteric-coated aspirin tablets (100 mg) produced by Bayer HealthCare Manufacturing S.r.l. as the reference preparation, to compare the pharmacokinetic parameters Cmax, AUC0-t, and AUC0-∞ of the two preparations, and to evaluate the bioequivalence of the two preparations in humans.

The main purpose of the study is to use the enteric-coated aspirin tablets of Nanjing Fengkaisi Pharmaceutical Research and Development Co., Ltd. as the test preparation and the enteric-coated aspirin tablets of BAYER S.P.A. as the reference preparation to evaluate the bioequivalence of the fasting and fed state in humans through a single-center, randomized, open, single-dose, two-preparation, four-cycle, two-sequence, completely repeated crossover study. The secondary purpose of the study is to observe the safety of the test preparation and the reference preparation in healthy Chinese subjects.