PURPOSE: Among healthy Chinese subjects, two capsules of dabigatran etexilate were tested for bioequivalence. METHOD: Fifty healthy subjects were recruited for each of the fasting and postprandial trials in a randomized, two-sequence, open-label, four-cycle, fully replicated trial design of a single 150 mg dose of either the test or the reference formulation of dabigatran etexilate capsules in the fasting and postprandial states. The blood concentration of dabigatran at different time points after administration was determined by high-performance liquid chromatography-tandem mass spectrometry (HPLC-MS/MS). The bioequivalence of the two formulations was evaluated by means of the main pharmacokinetic parameters and relative bioavailability. RESULTS: There were 39 males and 11 females in both fasting and postprandial groups. The age, height, weight and BMI of subjects in the fasting group were 19.0-41.0 years old, 148.5-182.0 cm, 46.1-81.0 kg and 19.2-25.7 kg/m CONCLUSION: The 2 dabigatran etexilate capsules were bioequivalent in both fasting and postprandial states and had favorable safety profile. TRIAL REGISTRATION: The enrollment process in this study was finalized on the "Chemical Drug Bioequivalence Trial Record Information Platform." ( http://www.chinadrugtrials.org.cn , 04/07/2023, CTR20231968).