Comparative Study of the Pharmacokinetics and Bioequivalence of Meldonium and Mildronate ® Preparations

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.