2005•Chinese Journal of New Drugs and Clinical RemediesRequires access

Human bioequivalence study of three kinds of telmisartan preparations

NG Qiang

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Abstract

AIM: To compare the bioavailability of domestic telmisartan tablets and capsules with imported telmisartan tablets. METHODS: This was an open randomized,three periods crssover study on twenty-fo ur healthy male volunteers. A reversed-phas e high performance liquid chromatography was used for the concentration determin ation of telmi sartan in serum after a single oral dose of 80 mg telmisartan tablets,capsules a nd imported telmisartan tablets in a crossover design. RESULTS: The phar macokine tic parameters of domestic telmisartan tablets,capsules and imported telmisarta n tablets were as follows: c_(max)(703±209),(703±196),(707±202)μg·L~ (-1);t_(max)(0.88±(0.15)),((0.91)± 0.18),(0.85±(0.13)h);AUC_(0-84)((17 863)±(7 223)),(17 9 95± 7 207),(17 950±(7 616))μg·h·L~(-1);AU C_(0-∞) (20 587±7 309),((20 732)±(7 129)),(20 960±7 420)μg·h·L~(-1);(MRT(35±5)),(35±5),(36±6)h;t _(1/2) :(2 5±(4)),(25±(4)),(26±5)h. CONCLUSION: Domestic telmisartan tablets and capsules are bioequivalent with the imported telmisartan tablets.

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AIM: To compare the bioavailability of domestic telmisartan tablets and capsules with imported telmisartan tablets. METHODS: This was an open randomized,three periods crssover study on twenty-fo ur healthy male volunteers. A reversed-phas e high performance liquid chromatography was used for the concentration determin ation of telmi sartan in serum after a single oral dose of 80 mg telmisartan tablets,capsules a nd imported telmisartan tablets in a crossover design. RESULTS: The phar macokine tic parameters of domestic telmisartan tablets,capsules and imported telmisarta n tablets were as follows: c_(max)(703±209),(703±196),(707±202)μg·L~ (-1);t_(max)(0.88±(0.15)),((0.91)± 0.18),(0.85±(0.13)h);AUC_(0-84)((17 863)±(7 223)),(17 9 95± 7 207),(17 950±(7 616))μg·h·L~(-1);AU C_(0-∞) (20 587±7 309),((20 732)±(7 129)),(20 960±7 420)μg·h·L~(-1);(MRT(35±5)),(35±5),(36±6)h;t _(1/2) :(2 5±(4)),(25±(4)),(26±5)h. CONCLUSION: Domestic telmisartan tablets and capsules are bioequivalent with the imported telmisartan tablets.

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Available abstract

AIM: To compare the bioavailability of domestic telmisartan tablets and capsules with imported telmisartan tablets. METHODS: This was an open randomized,three periods crssover study on twenty-fo ur healthy male volunteers. A reversed-phas e high performance liquid chromatography was used for the concentration determin ation of telmi sartan in serum after a single oral dose of 80 mg telmisartan tablets,capsules a nd imported telmisartan tablets in a crossover design. RESULTS: The phar macokine tic parameters of domestic telmisartan tablets,capsules and imported telmisarta n tablets were as follows: c_(max)(703±209),(703±196),(707±202)μg·L~ (-1);t_(max)(0.88±(0.15)),((0.91)± 0.18),(0.85±(0.13)h);AUC_(0-84)((17 863)±(7 223)),(17 9 95± 7 207),(17 950±(7 616))μg·h·L~(-1);AU C_(0-∞) (20 587±7 309),((20 732)±(7 129)),(20 960±7 420)μg·h·L~(-1);(MRT(35±5)),(35±5),(36±6)h;t _(1/2) :(2 5±(4)),(25±(4)),(26±5)h. CONCLUSION: Domestic telmisartan tablets and capsules are bioequivalent with the imported telmisartan tablets.

Key concepts: Telmisartan, Bioequivalence, Bioavailability, Crossover study, Pharmacology, Medicine, Chromatography, Chemistry

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