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

  • MOLECULAR-BIOLOGICAL PROBLEMS OF DRUG DESIGN AND MECHANISM OF DRUG ACTION
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Pharmaceutical Chemistry Journal Aims and scope

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.

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Authors and Affiliations

  1. E. D. Goldberg Research Institute of Pharmacology and Regenerative Medicine, Tomsk, 634028, Russia

    O. S. Bryushinina, E. A. Yanovskaya, Yu. G. Zyuz’kova, N. Yu. Abdrashitova, G. A. Frelikh & V. V. Udut

Authors
  1. O. S. Bryushinina
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  2. E. A. Yanovskaya
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  3. Yu. G. Zyuz’kova
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  4. N. Yu. Abdrashitova
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  5. G. A. Frelikh
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  6. V. V. Udut
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Corresponding author

Correspondence to O. S. Bryushinina.

Additional information

Translated from Khimiko-Farmatsevticheskii Zhurnal, Vol. 54, No. 9, pp. 3 – 8, September, 2020.

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Bryushinina, O.S., Yanovskaya, E.A., Zyuz’kova, Y.G. et al. Comparative Study of the Pharmacokinetics and Bioequivalence of Meldonium and Mildronate® Preparations. Pharm Chem J 54, 877–882 (2020). https://doi.org/10.1007/s11094-020-02291-y

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  • DOI: https://doi.org/10.1007/s11094-020-02291-y

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