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We compared newly developed delayed‐release oral tablets (test) of 30‐mg nifedipine (NFP) with its marketed counterpart (30 mg; reference) in healthy adult Chinese volunteers to assess the former's bioequivalence. This was a randomized, open‐label, four‐period, crossover trial study including fasting and fed trials. The participants were randomly administered test or reference formulations (1:1 ratio) throughout each period, with a 7‐day washout period. In the next session, they were administered the alternate products. Liquid chromatography–tandem mass spectrometry and WinNonlin software were used to evaluate the bioequivalence of the maximum plasma concentration (Cmax) of NFP and the area under the concentration–time curve (AUC). In total, 46 and 48 people participated in the fasting and postprandial trials. In both groups, the 90% confidence intervals of geometric mean ratios of Cmax, AUC from time zero to time t, and AUC from time zero to infinity were in the equivalence range (80%–125%). When NFP was administered concomitantly with a high‐fat meal, time to maximum concentration was approximately twofold earlier, absorption was approximately 4.8% less, and Cmax exhibited a slight change relative to those under fasting conditions. Moreover, no serious adverse events were recorded in the participants. The present findings confirm the bioequivalence of test and reference formulations of NFP tablets under fasting and postprandial conditions. [ABSTRACT FROM AUTHOR]

This study was designed to evaluate the bioequivalence of the newly developed delayed‐release oral suspension (test) 40 mg esomeprazole magnesium compared to its marketed counterpart (40 mg; reference) in healthy adult Chinese subjects. We conducted randomized, open‐label, two‐period, single‐dose, two‐way crossover trials over a 7‐day washout period, comprising a fasting trial and a fed trial. The subjects were administered the test or reference products in a 1:1 ratio at random throughout each period. Then, in the next session, they received the alternate products. Liquid chromatography‐tandem mass spectrometry and WinNonlin software were used to assess the bioequivalence of esomeprazole peak plasma concentration (Cmax) and area under the concentration–time curve (AUC). Overall, 33 subjects participated in the fasting trial and 42 subjects participated in the fed trial. Under both situations, the 90% confidence interval for the ratio of geometric means of Cmax, AUC0‐t, and AUC0‐∞ were within equivalence ranges (80%–125%). In these trials, no severe adverse events or protocol violations were observed. Moreover, when esomeprazole was administered while fed, the tmax was delayed, and both Cmax and AUC were reduced. The results of this research suggest that the test and reference formulations were bioequivalent under fasting and fed states. [ABSTRACT FROM AUTHOR]

The aim of this study was to explore the bioequivalence of miglitol based on pharmacodynamic properties. The study was performed as a single‐dose, randomized, open‐label, 3‐period, 3‐way crossover trial over a 7‐day washout period. Forty‐eight subjects were randomly assigned into 3 groups: (1) miglitol test formulation/sucrose coadministration, (2) miglitol reference formulation/sucrose coadministration, and (3) sucrose administration alone. Serum glucose concentrations were measured by the hexokinase detection method. The peak serum glucose concentration (Cmax) and the area under the serum glucose concentration‐time curve through 4 hours (AUC0‐4h) were used as the main pharmacodynamic parameters to evaluate bioequivalence. The 90% confidence intervals for the geometric mean ratios of Cmax and AUC0‐4h were 94.81%‐101.07% and 98.82%‐100.72%, respectively, which were all within the bioequivalence range of 80.00%‐125.00%. The test and reference formulations of miglitol were pharmacodynamically bioequivalent during the trial. [ABSTRACT FROM AUTHOR]