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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 a...
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| Published in: | Pharmaceutical chemistry journal 2020-12, Vol.54 (9), p.877-882 |
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| Main Authors: | , , , , , |
| Format: | Article |
| Language: | English |
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| cites | cdi_FETCH-LOGICAL-c242t-6aeb8ecd950f4747e1dd690b207190a42be55d2cbd2c1cdf5ef5814ac687bde33 |
| container_end_page | 882 |
| container_issue | 9 |
| container_start_page | 877 |
| container_title | Pharmaceutical chemistry journal |
| container_volume | 54 |
| creator | Bryushinina, O. S. Yanovskaya, E. A. Zyuz’kova, Yu. G. Abdrashitova, N. Yu Frelikh, G. A. Udut, V. V. |
| description | 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
AUC
0-t
(86.32 – 102.48%),
AUC
0-∞
(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. |
| doi_str_mv | 10.1007/s11094-020-02291-y |
| format | article |
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AUC
0-t
(86.32 – 102.48%),
AUC
0-∞
(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.</description><identifier>ISSN: 0091-150X</identifier><identifier>EISSN: 1573-9031</identifier><identifier>DOI: 10.1007/s11094-020-02291-y</identifier><language>eng</language><publisher>New York: Springer US</publisher><subject>Medicine ; Molecular-Biological Problems of Drug Design and Mechanism of Drug Action ; Organic Chemistry ; Pharmacology/Toxicology ; Pharmacy</subject><ispartof>Pharmaceutical chemistry journal, 2020-12, Vol.54 (9), p.877-882</ispartof><rights>Springer Science+Business Media, LLC, part of Springer Nature 2020</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><cites>FETCH-LOGICAL-c242t-6aeb8ecd950f4747e1dd690b207190a42be55d2cbd2c1cdf5ef5814ac687bde33</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,780,784,27924,27925</link.rule.ids></links><search><creatorcontrib>Bryushinina, O. S.</creatorcontrib><creatorcontrib>Yanovskaya, E. A.</creatorcontrib><creatorcontrib>Zyuz’kova, Yu. G.</creatorcontrib><creatorcontrib>Abdrashitova, N. Yu</creatorcontrib><creatorcontrib>Frelikh, G. A.</creatorcontrib><creatorcontrib>Udut, V. V.</creatorcontrib><title>Comparative Study of the Pharmacokinetics and Bioequivalence of Meldonium and Mildronate® Preparations</title><title>Pharmaceutical chemistry journal</title><addtitle>Pharm Chem J</addtitle><description>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
AUC
0-t
(86.32 – 102.48%),
AUC
0-∞
(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.</description><subject>Medicine</subject><subject>Molecular-Biological Problems of Drug Design and Mechanism of Drug Action</subject><subject>Organic Chemistry</subject><subject>Pharmacology/Toxicology</subject><subject>Pharmacy</subject><issn>0091-150X</issn><issn>1573-9031</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2020</creationdate><recordtype>article</recordtype><recordid>eNp9kEFOwzAQRS0EEqVwAVa5QGDsJE2zhAooUisqARI7y7EnrUtiFzuplEtxCE6G27Bm8TXSzP9fo0fINYUbCpDfekqhSGNgEMQKGvcnZESzPIkLSOgpGQGEJc3g45xceL8FCLGEjch6ZpudcKLVe4xe2071ka2idoPRaiNcI6T91AZbLX0kjIrutcWvTu9FjUbiwbrEWlmju-Z4X-paOWtEiz_f0crhUG2NvyRnlag9Xv3NMXl_fHibzePFy9Pz7G4RS5ayNp4ILKcoVZFBleZpjlSpSQElg5wWIFJWYpYpJssgKlWVYZVNaSrkZJqXCpNkTNjQK5313mHFd043wvWcAj-g4gMqHlDxIyreh1AyhHwwmzU6vrWdM-HP_1K_EUBwjQ</recordid><startdate>20201201</startdate><enddate>20201201</enddate><creator>Bryushinina, O. S.</creator><creator>Yanovskaya, E. A.</creator><creator>Zyuz’kova, Yu. G.</creator><creator>Abdrashitova, N. Yu</creator><creator>Frelikh, G. A.</creator><creator>Udut, V. V.</creator><general>Springer US</general><scope>AAYXX</scope><scope>CITATION</scope></search><sort><creationdate>20201201</creationdate><title>Comparative Study of the Pharmacokinetics and Bioequivalence of Meldonium and Mildronate® Preparations</title><author>Bryushinina, O. S. ; Yanovskaya, E. A. ; Zyuz’kova, Yu. G. ; Abdrashitova, N. Yu ; Frelikh, G. A. ; Udut, V. V.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c242t-6aeb8ecd950f4747e1dd690b207190a42be55d2cbd2c1cdf5ef5814ac687bde33</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2020</creationdate><topic>Medicine</topic><topic>Molecular-Biological Problems of Drug Design and Mechanism of Drug Action</topic><topic>Organic Chemistry</topic><topic>Pharmacology/Toxicology</topic><topic>Pharmacy</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Bryushinina, O. S.</creatorcontrib><creatorcontrib>Yanovskaya, E. A.</creatorcontrib><creatorcontrib>Zyuz’kova, Yu. G.</creatorcontrib><creatorcontrib>Abdrashitova, N. Yu</creatorcontrib><creatorcontrib>Frelikh, G. A.</creatorcontrib><creatorcontrib>Udut, V. V.</creatorcontrib><collection>CrossRef</collection><jtitle>Pharmaceutical chemistry journal</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Bryushinina, O. S.</au><au>Yanovskaya, E. A.</au><au>Zyuz’kova, Yu. G.</au><au>Abdrashitova, N. Yu</au><au>Frelikh, G. A.</au><au>Udut, V. V.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Comparative Study of the Pharmacokinetics and Bioequivalence of Meldonium and Mildronate® Preparations</atitle><jtitle>Pharmaceutical chemistry journal</jtitle><stitle>Pharm Chem J</stitle><date>2020-12-01</date><risdate>2020</risdate><volume>54</volume><issue>9</issue><spage>877</spage><epage>882</epage><pages>877-882</pages><issn>0091-150X</issn><eissn>1573-9031</eissn><abstract>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
AUC
0-t
(86.32 – 102.48%),
AUC
0-∞
(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.</abstract><cop>New York</cop><pub>Springer US</pub><doi>10.1007/s11094-020-02291-y</doi><tpages>6</tpages></addata></record> |
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| ispartof | Pharmaceutical chemistry journal, 2020-12, Vol.54 (9), p.877-882 |
| issn | 0091-150X 1573-9031 |
| language | eng |
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| source | Springer Link |
| subjects | Medicine Molecular-Biological Problems of Drug Design and Mechanism of Drug Action Organic Chemistry Pharmacology/Toxicology Pharmacy |
| title | Comparative Study of the Pharmacokinetics and Bioequivalence of Meldonium and Mildronate® Preparations |
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