| Popis: |
Purpose Eldecalcitol is an active vitamin D3 derivative for preventing and treating osteoporosis. The objectives of this study was to evaluate the bioequivalence and safety of two formulations of eldecalcitol capsule (0.75 µg) in healthy Chinese male and female volunteers, as well as to investigate the food effect on the pharmacokinetics. Methods An open-label, randomized, three-period, three-sequence, reference-replicated crossover clinical study was performed in 27 healthy Chinese volunteers under fasting condition. Meanwhile, a two-way crossover study was performed in 28 healthy Chinese volunteers under fed condition. Subjects were administered with a single oral dose of 0.75 µg eldecalcitol after an overnight fast. The washout time between each period was 25 days. Blood samples were collected with scheduled time points from 0 to168 h. Results The 90% confidence intervals (CI) of test/reference AUC ratio and Cmax ratio of the eldecalcitol were within the acceptance criteria based on average bioequivalence method. Tmax of test and reference formulation were 3.987 h and 3.489 h under the fasting conditions. While Tmax was prolonged to 9.006 h and 6.007 h in test and reference formulation after a high-fat meal. Only mild and transient, but not severe adverse events were detected in the study. Conclusion Two formulations of eldecalcitol was bioequivalent under both fasting and fed conditions. Whereas, food intake prolonged the oral absorption of eldecalcitol, but did not significantly influence the system exposure. |
