2005Chinese New Drugs JournalRequires access

The relative bioavailability of telmisartan tablets

Ling Gao

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Abstract

Objective: To evaluate the pharmacokinetics and relative bioavailability of telmisartan tablets imported (test) versus locally manufactured (reference). Methods:20 healthy male volunteers were randomly administered a single crossover dose of 80mg test and reference tablets. Plasma telmisartan concentration was determined by HPLC-Fluorescent analysis, and the relative bioavailability and bioequivalence of the tablets analyzed using the 3p97 program. Results: The pharmacokinetic parameters of test and reference tablets were as follows: T_(max)(0. 91±0.19) vs. (0.86±0.21)h; C_(max) (672.7±275. 1) vs. (710. 2 ± 312. 9) μg?mL~(-1); AUC_(0~t) (4221. 4 ± 2909. 0) vs. (4430. 2±3487.9)μg·h·L~(-1); AUC_(0~∞)(4 568.1±3 032. 5) vs. (4 742. 6 + 3 657. 3)μg·h·L~(-1); t_(1/2)(30.7± 7.0) vs. (28.0 ± 5.9)h.The relative bioavailability of the test formulation was (98.1±12.1) %. Conclusion: The test tablets are bioequivalent to the reference tablets.

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Objective: To evaluate the pharmacokinetics and relative bioavailability of telmisartan tablets imported (test) versus locally manufactured (reference). Methods:20 healthy male volunteers were randomly administered a single crossover dose of 80mg test and reference tablets. Plasma telmisartan concentration was determined by HPLC-Fluorescent analysis, and the relative bioavailability and bioequivalence of the tablets analyzed using the 3p97 program. Results: The pharmacokinetic parameters of test and reference tablets were as follows: T_(max)(0. 91±0.19) vs. (0.86±0.21)h; C_(max) (672.7±275. 1) vs. (710. 2 ± 312. 9) μg?mL~(-1); AUC_(0~t) (4221. 4 ± 2909. 0) vs. (4430. 2±3487.9)μg·h·L~(-1); AUC_(0~∞)(4 568.1±3 032. 5) vs. (4 742. 6 + 3 657. 3)μg·h·L~(-1); t_(1/2)(30.7± 7.0) vs. (28.0 ± 5.9)h.The relative bioavailability of the test formulation was (98.1±12.1) %. Conclusion: The test tablets are bioequivalent to the reference tablets.

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Available abstract

Objective: To evaluate the pharmacokinetics and relative bioavailability of telmisartan tablets imported (test) versus locally manufactured (reference). Methods:20 healthy male volunteers were randomly administered a single crossover dose of 80mg test and reference tablets. Plasma telmisartan concentration was determined by HPLC-Fluorescent analysis, and the relative bioavailability and bioequivalence of the tablets analyzed using the 3p97 program. Results: The pharmacokinetic parameters of test and reference tablets were as follows: T_(max)(0. 91±0.19) vs. (0.86±0.21)h; C_(max) (672.7±275. 1) vs. (710. 2 ± 312. 9) μg?mL~(-1); AUC_(0~t) (4221. 4 ± 2909. 0) vs. (4430. 2±3487.9)μg·h·L~(-1); AUC_(0~∞)(4 568.1±3 032. 5) vs. (4 742. 6 + 3 657. 3)μg·h·L~(-1); t_(1/2)(30.7± 7.0) vs. (28.0 ± 5.9)h.The relative bioavailability of the test formulation was (98.1±12.1) %. Conclusion: The test tablets are bioequivalent to the reference tablets.

Key concepts: Bioequivalence, Bioavailability, Telmisartan, Pharmacokinetics, Crossover study, Pharmacology, Medicine, Plasma concentration

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