Pharmacokinetics and bioequivalence of telmisartan tablets and capsules
Zhai Suo-di
Abstract
Zhai Suo-di
Abstract
Objective: To evaluate the pharmacokinetics and bioequivalence of telmisartan tablets and capsules. Methods: 18 healthy volunteers were randomized to orally receive one of single dose telmisartan capsules, test tablets or reference tablets (40mg) in a 3×3 Latin Square crossover clinical trial. Plasma telmisartan concentrations were measured by HPLC with fluorescence detection. Results: The pharmacokinetic parameters of telmisartan capsules, test tablets, and reference tablets without significant difference were as follows: C_(max)(88.78±52.71)vs. (87.06±43.23)vs. (91.63±41.80)μg·L~(-1); T_(max)(2.08±1.22)vs. (2.97±5.38)vs. (1.78±0.65)h; t_(1/2)(33.22±13.53)vs. (33.82±14.27)vs. (30.76±9.77)h; AUC_(0-t)(1195.28±586.21)vs. (1168.43±629.11)vs. (1211.69±594.97)μg·h·L~(-1). The relative bioavailability of telmisartan test tablets and capsules were (98.21±22.34)% and (102.95±32.14)%, respectively. Conclusion: Three formations of telmisartan were bioequivalent (CI 90%).
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Objective: To evaluate the pharmacokinetics and bioequivalence of telmisartan tablets and capsules. Methods: 18 healthy volunteers were randomized to orally receive one of single dose telmisartan capsules, test tablets or reference tablets (40mg) in a 3×3 Latin Square crossover clinical trial. Plasma telmisartan concentrations were measured by HPLC with fluorescence detection. Results: The pharmacokinetic parameters of telmisartan capsules, test tablets, and reference tablets without significant difference were as follows: C_(max)(88.78±52.71)vs. (87.06±43.23)vs. (91.63±41.80)μg·L~(-1); T_(max)(2.08±1.22)vs. (2.97±5.38)vs. (1.78±0.65)h; t_(1/2)(33.22±13.53)vs. (33.82±14.27)vs. (30.76±9.77)h; AUC_(0-t)(1195.28±586.21)vs. (1168.43±629.11)vs. (1211.69±594.97)μg·h·L~(-1). The relative bioavailability of telmisartan test tablets and capsules were (98.21±22.34)% and (102.95±32.14)%, respectively. Conclusion: Three formations of telmisartan were bioequivalent (CI 90%).
Key concepts: Telmisartan, Bioequivalence, Pharmacokinetics, Bioavailability, Crossover study, Medicine, Pharmacology, Chromatography