A randomized, open-label, single-dose, two-way crossover study to assess the pharmacokinetics between two tablets of fixed-dose combination formulation with raloxifene and cholecalciferol and concomitant administration of each agents in healthy male volu

다국어 초록 (Multilingual Abstract)

A new fixed-dose combination (FDC) formulation of raloxifene 60 mg and cholecalciferol 800IU was developed to improve the medication compliance and overall efficacy of raloxifenetreatment in postmenopausal osteoporosis patients. The aim of this study was to comparethe pharmacokinetics between two tablets of FDC formulation of raloxifene/cholecalciferoland the two products administered concomitantly at respective doses. This randomized,open-label, single-dose, two-treatment, two-way crossover study included 46 volunteers.
During each treatment period, subjects received the test formulation (FDC formulationcontaining raloxifene and cholecalciferol) or the reference formulation (co-administration ofraloxifene and cholecalciferol), with a 14-d washout period. Serial blood samples were collectedperiodically over 96 hours after drug intake. In total, 46 subjects completed the study. Thegeometric mean ratios and its 90% confidence inter vals of the FDC to the single agents for thearea under the concentration-time cur ve from zero to the last quantifiable time point and themaximum plasma concentration met the regulator y criteria for bioequivalence: 1.1364 (1.0584–1.2201) and 1.1010 (0.9945–1.2188) for raloxifene and 1.0266 (0.9591–1.0989) and 1.0354(0.9816–1.0921) for baseline-corrected cholecalciferol, respectively. Both formulations were welltolerated. No significant differences was obser ved in the incidence of adverse events betweenthe two treatments. It was concluded that two tablets of the newly developed FDC formulationof raloxifene and cholecalciferol and the corresponding two agents administered concomitantlyat respective doses were bioequivalent.

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