MOLECULAR-BIOLOGICAL PROBLEMS OF DRUG DESIGN AND MECHANISM OF DRUG ACTION COMPARATIVE STUDY OF THE PHARMACOKINETICS AND BIOEQUIVALENCE OF MELDONIUM AND MILDRONATE ® PREPARATIONS

A comparative 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 AUC 0-t (86.32 – 102.48%), AUC 0- (cid:2) (85.30 – 101.68%), and C max (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.