The present study aimed to compare pharmacokinetic parameters of two pramipexole\n0.25 mg formulations in order to show bioequivalence. The study was conducted in a randomized,\nopen-label, two-period, two-sequence, and crossover design, involving 23 healthy volunteers. One of\nthe 0.25 mg formulations of pramipexole evaluated in the study was manufactured by PT Dexa\nMedica, Palembang, Indonesia, the other, used as the reference, by Boehringer Ingelheim Pharma\nGmbH & Co. KG, Ingelheim am Rhein, Germany. All eligible subjects were required to fast\nbefore each drug administration period, which was separated by a one-week washout period.\nPramipexole concentrations in plasma were assayed using a validated ultra performance liquid\nchromatography with mass spectrometry (UPLC-MS/MS) detector. The evaluated pharmacokinetic\nparameters included the area under the plasma concentration curve from time zero to the last observed\nmeasurable concentration (AUC0-t), the area under the plasma concentration curve extrapolated to\ninfinite time (AUC0-âË?ž), the maximum plasma concentration (Cmax), the time to reach Cmax (tmax),\nand the plasma concentration half-life (t1/2). To evaluate the bioequivalence of those two pramipexole\nformulations, 90% confidence intervals (CIs) for geometric mean ratios of both formulations were\ncalculated for AUC and Cmax parameters, while tmax and t1/2 differences were analyzed on the\nnon-transformed data using Wilcoxon matched-pairs and a Studentââ?¬â?¢s paired t-test, respectively.\nThe 90% CIs for the geometric mean ratios of the two pramipexole formulations were 95.89%\n(90.73%ââ?¬â??101.34%), 95.53% (89.75%ââ?¬â??101.68%), and 92.11% (84.35%ââ?¬â??100.58%) for AUC0-t, AUC0-âË?ž,\nand Cmax, respectively. There were no statistically significant differences for tmax and t1/2 between\nthe two pramipexole formulations. It is concluded that two pramipexole formulations in this study\nwere bioequivalent.
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