Acomparative study of the pharmacokinetics, bioequivalence, and safety of two marketed meldonium dosage forms Meldonium Organika (meldonium, 500 mg capsules, Organika Co., Russia) and Mildronate® (meldonium, 500 mg capsules, Grindex Co., Latvia) was carried out for a group of healthy volunteers in an open randomized 2-period cross-validation test. It was established that 90% confidence intervals for the ratio of geometric means of pharmacokinetic parameters AUC0-t (86.32 – 102.48%), AUC0-∞ (85.30 – 101.68%), and Cmax (84.92 – 101.76%) did not go beyond permissible limits of 80.00 – 125.00%. A conclusion was made about the bioequivalence of the aforementioned meldonium preparations based on the drug pharmacokinetic parameters.

中文翻译：

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米曲肼和米屈膦酸盐®制剂的药代动力学和生物等效性的比较研究

对两种已上市米屈肼剂型米曲肼（米屈肼，500 毫克胶囊，Organika Co.，俄罗斯）和 Mildronate®（米屈肼，500 毫克胶囊，拉脱维亚 Grindex 公司）的药代动力学、生物等效性和安全性进行了比较研究在开放式随机 2 期交叉验证测试中针对一组健康志愿者。已确定药代动力学参数 AUC0-t (86.32 – 102.48%)、AUC0-∞ (85.30 – 101.68%) 和 Cmax (84.92 – 101.76%) 的几何平均值比的 90% 置信区间没有超出允许范围80.00 – 125.00% 的限制。根据药物的药代动力学参数，对上述米曲肼制剂的生物等效性作出结论。