COMPARATIVE PHARMACOKINETICS AND EFFECT ON THE HEMODYNAMICS OF ORIGINAL AND GENERIC NEBIVOLOL IN HEALTHY VOLUNTEERS
Beta-blockers are an important part of modern pharmacotherapy in cardiology. The introduction of generics into clinical practice requires clear evidence of bioequivalence to the original drug.Aim. To study the pharmacokinetics and effect on hemodynamic parameters of the original and a generic nebivo...
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Столичная издательская компания
2016-05-01
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| Series: | Рациональная фармакотерапия в кардиологии |
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| Online Access: | https://www.rpcardio.online/jour/article/view/1234 |
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| author | E. I. Bambysheva K. V. Isaeva M. M. Makhinova D. T. Guranda V. G. Belolipetskaya |
| author_facet | E. I. Bambysheva K. V. Isaeva M. M. Makhinova D. T. Guranda V. G. Belolipetskaya |
| author_sort | E. I. Bambysheva |
| collection | DOAJ |
| description | Beta-blockers are an important part of modern pharmacotherapy in cardiology. The introduction of generics into clinical practice requires clear evidence of bioequivalence to the original drug.Aim. To study the pharmacokinetics and effect on hemodynamic parameters of the original and a generic nebivolol in healthy volunteers in the fasting state. Material and methods. 18 healthy volunteers were included into the randomized open study on cross-balanced design. They received single dose (5 mg) of two compared preparations of nebivolol under fasting condition. The concentration of unchanged nebivolol in blood plasma was determined by gas chromatography-tandem mass spectrometry. Calculation of pharmacokinetic parameters and assessment of the hemodynamic were performed.Results. The concentrations of nebivolol after the original and generic drugs intake did not differ significantly in any time point (AUC0-∞ 41.09±46.82 vs 47.16±66.58 ng•hr/mL and T1/2 30.84±10.78 vs 29.59±12.08 hours, respectively). Blood pressure reduction was slightly more pronounced when taking generic nebivolol, while the reduction in heart rate at 2 and 4 hours – after original nebivolol intake.Conclusion. A comparative pharmacokinetic study of the genetic nebivolol showed its bioequivalence to the original drug. The effect on hemodynamic parameters with single dose (5 mg) of generic and original nebivolol in healthy volunteers was comparable. |
| format | Article |
| id | doaj-art-aaba2de1f7ce4ae9a94fd50d8a0ff38b |
| institution | Matheson Library |
| issn | 1819-6446 2225-3653 |
| language | English |
| publishDate | 2016-05-01 |
| publisher | Столичная издательская компания |
| record_format | Article |
| series | Рациональная фармакотерапия в кардиологии |
| spelling | doaj-art-aaba2de1f7ce4ae9a94fd50d8a0ff38b2025-07-03T07:28:31ZengСтоличная издательская компанияРациональная фармакотерапия в кардиологии1819-64462225-36532016-05-0112217117510.20996/1819-6446-2016-12-2-171-1751201COMPARATIVE PHARMACOKINETICS AND EFFECT ON THE HEMODYNAMICS OF ORIGINAL AND GENERIC NEBIVOLOL IN HEALTHY VOLUNTEERSE. I. Bambysheva0K. V. Isaeva1M. M. Makhinova2D. T. Guranda3V. G. Belolipetskaya4State Research Centre for Preventive Medicine, MoscowState Research Centre for Preventive Medicine, MoscowState Research Centre for Preventive Medicine, MoscowLimited liability company "Farm InnTeh", Odintsovo, Moscow RegionState Research Centre for Preventive Medicine, MoscowBeta-blockers are an important part of modern pharmacotherapy in cardiology. The introduction of generics into clinical practice requires clear evidence of bioequivalence to the original drug.Aim. To study the pharmacokinetics and effect on hemodynamic parameters of the original and a generic nebivolol in healthy volunteers in the fasting state. Material and methods. 18 healthy volunteers were included into the randomized open study on cross-balanced design. They received single dose (5 mg) of two compared preparations of nebivolol under fasting condition. The concentration of unchanged nebivolol in blood plasma was determined by gas chromatography-tandem mass spectrometry. Calculation of pharmacokinetic parameters and assessment of the hemodynamic were performed.Results. The concentrations of nebivolol after the original and generic drugs intake did not differ significantly in any time point (AUC0-∞ 41.09±46.82 vs 47.16±66.58 ng•hr/mL and T1/2 30.84±10.78 vs 29.59±12.08 hours, respectively). Blood pressure reduction was slightly more pronounced when taking generic nebivolol, while the reduction in heart rate at 2 and 4 hours – after original nebivolol intake.Conclusion. A comparative pharmacokinetic study of the genetic nebivolol showed its bioequivalence to the original drug. The effect on hemodynamic parameters with single dose (5 mg) of generic and original nebivolol in healthy volunteers was comparable.https://www.rpcardio.online/jour/article/view/1234nebivololpharmacokineticshealthy volunteersbioequivalence |
| spellingShingle | E. I. Bambysheva K. V. Isaeva M. M. Makhinova D. T. Guranda V. G. Belolipetskaya COMPARATIVE PHARMACOKINETICS AND EFFECT ON THE HEMODYNAMICS OF ORIGINAL AND GENERIC NEBIVOLOL IN HEALTHY VOLUNTEERS Рациональная фармакотерапия в кардиологии nebivolol pharmacokinetics healthy volunteers bioequivalence |
| title | COMPARATIVE PHARMACOKINETICS AND EFFECT ON THE HEMODYNAMICS OF ORIGINAL AND GENERIC NEBIVOLOL IN HEALTHY VOLUNTEERS |
| title_full | COMPARATIVE PHARMACOKINETICS AND EFFECT ON THE HEMODYNAMICS OF ORIGINAL AND GENERIC NEBIVOLOL IN HEALTHY VOLUNTEERS |
| title_fullStr | COMPARATIVE PHARMACOKINETICS AND EFFECT ON THE HEMODYNAMICS OF ORIGINAL AND GENERIC NEBIVOLOL IN HEALTHY VOLUNTEERS |
| title_full_unstemmed | COMPARATIVE PHARMACOKINETICS AND EFFECT ON THE HEMODYNAMICS OF ORIGINAL AND GENERIC NEBIVOLOL IN HEALTHY VOLUNTEERS |
| title_short | COMPARATIVE PHARMACOKINETICS AND EFFECT ON THE HEMODYNAMICS OF ORIGINAL AND GENERIC NEBIVOLOL IN HEALTHY VOLUNTEERS |
| title_sort | comparative pharmacokinetics and effect on the hemodynamics of original and generic nebivolol in healthy volunteers |
| topic | nebivolol pharmacokinetics healthy volunteers bioequivalence |
| url | https://www.rpcardio.online/jour/article/view/1234 |
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