Pharmacokinetic and bioequivalence study of Telzap® in comparison with Mikardis® in healthy subjects after single administrationl
Introduction. Telmisartan is widely used in clinical practice during hypertension treatment. It is a specific angiotensin II receptor antagonist (type AT1), effective at oral intake, A bioequivalence study of Telzap® and Mikardis® was conducted with 60 volunteers.Aim. The purpose of the bioequivalen...
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2023-01-01
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| Series: | Фармакокинетика и Фармакодинамика |
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| Online Access: | https://www.pharmacokinetica.ru/jour/article/view/345 |
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| author | A. L. Khokhlov A. A. Khokhlov A. E. Miroshnikov O. V. Lebedeva D. Yu. Grebenkin |
| author_facet | A. L. Khokhlov A. A. Khokhlov A. E. Miroshnikov O. V. Lebedeva D. Yu. Grebenkin |
| author_sort | A. L. Khokhlov |
| collection | DOAJ |
| description | Introduction. Telmisartan is widely used in clinical practice during hypertension treatment. It is a specific angiotensin II receptor antagonist (type AT1), effective at oral intake, A bioequivalence study of Telzap® and Mikardis® was conducted with 60 volunteers.Aim. The purpose of the bioequivalence trial was a comparative study of the pharmacokinetics and evidence of the bioequivalence of Mikardis® (telmisartan, tablets 80 mg, Boehringer Ingelheim International GmbH, Germany) and Telzap® (telmisartan, tablets 80 mg, Zentiva KS company, Czech Republic) in healthy volunteers after a single administration under fasting.Materials and methods. To prove bioequivalence, an open label, comparative, randomized, crossover four-period replicate single-center clinical trial was conducted. The concentrations of telmisartan in plasma samples were determined by a validated HPLC-MS/MS method. A pharmacokinetic and statistical analysis was performed and confidence intervals for the pharmacokinetic parameters Cmax and AUC0-72 were calculated.Results and discussion. It can be concluded that the studied formulations are bioequivalent in terms of pharmacokinetic parameters of test and reference drug. All 90 % confidence intervals of were within the bioequivalence range of 80–125 % for AUC0-72 and 73,07–136,85 % for Cmax.Conclusion. Thus, according to the criteria used in the study, the formulations are proved to be bioequivalent. |
| format | Article |
| id | doaj-art-ff1640f633fc48e1a62395e7297568f5 |
| institution | Kabale University |
| issn | 2587-7836 2686-8830 |
| language | Russian |
| publishDate | 2023-01-01 |
| publisher | LLC “Publisher OKI” |
| record_format | Article |
| series | Фармакокинетика и Фармакодинамика |
| spelling | doaj-art-ff1640f633fc48e1a62395e7297568f52025-08-20T03:42:30ZrusLLC “Publisher OKI”Фармакокинетика и Фармакодинамика2587-78362686-88302023-01-0104626810.37489/2587-7836-2022-4-62-68321Pharmacokinetic and bioequivalence study of Telzap® in comparison with Mikardis® in healthy subjects after single administrationlA. L. Khokhlov0A. A. Khokhlov1A. E. Miroshnikov2O. V. Lebedeva3D. Yu. Grebenkin4Federal State Budgetary Educational Institution of Higher Education «Yaroslavl State Medical University» of the Ministry of Healthcare of the Russian FederationLLC «AX CT»LLC ClinPharmInvestRepresentative office of Sanofi-aventis group JSC (France)LLC Exacte LabsIntroduction. Telmisartan is widely used in clinical practice during hypertension treatment. It is a specific angiotensin II receptor antagonist (type AT1), effective at oral intake, A bioequivalence study of Telzap® and Mikardis® was conducted with 60 volunteers.Aim. The purpose of the bioequivalence trial was a comparative study of the pharmacokinetics and evidence of the bioequivalence of Mikardis® (telmisartan, tablets 80 mg, Boehringer Ingelheim International GmbH, Germany) and Telzap® (telmisartan, tablets 80 mg, Zentiva KS company, Czech Republic) in healthy volunteers after a single administration under fasting.Materials and methods. To prove bioequivalence, an open label, comparative, randomized, crossover four-period replicate single-center clinical trial was conducted. The concentrations of telmisartan in plasma samples were determined by a validated HPLC-MS/MS method. A pharmacokinetic and statistical analysis was performed and confidence intervals for the pharmacokinetic parameters Cmax and AUC0-72 were calculated.Results and discussion. It can be concluded that the studied formulations are bioequivalent in terms of pharmacokinetic parameters of test and reference drug. All 90 % confidence intervals of were within the bioequivalence range of 80–125 % for AUC0-72 and 73,07–136,85 % for Cmax.Conclusion. Thus, according to the criteria used in the study, the formulations are proved to be bioequivalent.https://www.pharmacokinetica.ru/jour/article/view/345telmisartanpharmacokineticsbioequivalence |
| spellingShingle | A. L. Khokhlov A. A. Khokhlov A. E. Miroshnikov O. V. Lebedeva D. Yu. Grebenkin Pharmacokinetic and bioequivalence study of Telzap® in comparison with Mikardis® in healthy subjects after single administrationl Фармакокинетика и Фармакодинамика telmisartan pharmacokinetics bioequivalence |
| title | Pharmacokinetic and bioequivalence study of Telzap® in comparison with Mikardis® in healthy subjects after single administrationl |
| title_full | Pharmacokinetic and bioequivalence study of Telzap® in comparison with Mikardis® in healthy subjects after single administrationl |
| title_fullStr | Pharmacokinetic and bioequivalence study of Telzap® in comparison with Mikardis® in healthy subjects after single administrationl |
| title_full_unstemmed | Pharmacokinetic and bioequivalence study of Telzap® in comparison with Mikardis® in healthy subjects after single administrationl |
| title_short | Pharmacokinetic and bioequivalence study of Telzap® in comparison with Mikardis® in healthy subjects after single administrationl |
| title_sort | pharmacokinetic and bioequivalence study of telzap r in comparison with mikardis r in healthy subjects after single administrationl |
| topic | telmisartan pharmacokinetics bioequivalence |
| url | https://www.pharmacokinetica.ru/jour/article/view/345 |
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