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Sarpogrelate is widely used to treat peripheral vascular disorders. However, it has been demonstrated to have a poor pharmacokinetic (PK) profile and marked within‐subject variability. Here, the bioequivalence of 2 formulations of sarpogrelate (100‐mg tablets) was assessed by using the reference‐scaled average bioequivalence (RSABE) method, and the PK parameters were quantified in healthy Chinese subjects under fasting (n = 38) and fed (n = 35) conditions. In this open and randomized 4‐way replicate study, a single dose of sarpogrelate was administered followed by a 3‐day washout period. The sarpogrelate concentration in blood samples was measured by liquid chromatography‐tandem mass spectrometry within 6 hours (fasting) or 10 hours (fed) of drug administration, and the PK parameters were determined by a noncompartmental model. The bioequivalence of the 2 formulations under both conditions was assessed using the ratios of ln(peak concentration [Cmax]) and ln(area under the concentration‐time curve [AUC]) within the limits based on the RSABE method. The 90% CIs for the ratios of lnCmax, lnAUC0‐t, and lnAUC0‐∞ were 0.8531–1.1100, 0.9616–1.0737, and 0.9550–1.0684, respectively, under fasting conditions and 0.8918–1.1076, 0.9818–1.0694, and 0.9818–1.0686, respectively, under fed conditions, which were within the RSABE acceptance limits. Food intake decreased the systemic exposure and the Cmax of sarpogrelate by 0.9‐fold and 0.5‐fold, respectively.

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made between the two breathing traces to evaluate the phase shift in signal acquisition and the difference in breathing patterns. Two sets of 4DCT images with the same raw sinogram data for the same patient were reconstructed using the respiratory signals acquired by both systems. An amplitude-based sorting algorithm was applied to obtain the images of ten respiratory phases. The images reconstructed from the two different respiratory signals were compared for each individual phase. Image segmentation was performed in the treatment planning system to assess the differences in lung contours and the position of the diaphragm. Results: The phase shifts calculated by the time latency at the end inhalation between the two breathing traces were consistent for all ten patients and were measured as 0.2AE0.1 seconds. The breathing trace measured by the Anzai pressure sensor had a steeper falloff curve during exhalation than the RPM trace measured by the abdominal surface movement. In the 4DCT images reconstructed separately, changes in lung contouring and shifts in position of diaphragm were observed in each individual phase. Largest shifts of more than 5mm in the diaphragm location were found in phases between 40% exhalation and 20% inhalation. Conclusion: Phase shifts between breathing traces and differences in breathing patterns as measured by the abdominal pressure change and surface displacement were observed in this study. The internal thoracic motion during 4DCT scan can have different correlation relationships with different respiratory monitoring systems using external surrogates. This implicates that mixed use of different respiratory monitoring systems in 4DCT imaging for treatment planning and in respiratory gated treatment delivery may result in errors in the dose distribution received by the patient.