Title: Bioequivalence of losartan capsule and tablet in healthy volunteers
Abstract: Objective To evaluate the bioequivalence of test and reference losartan potassium formulations in healthy volunteers. Methods A single oral dose of 50 mg test or reference preparation was administrated to 20 healthy volunteers in a randomized cross-over study. The pharmacokinetic parameters were calculated.Results For losartan test (its capsule) and reference (its tablet) formulations,C_ max were (317.42 ± 217.05 ) ng·mL~ -1 and (295.57 ± 132.16) ng·mL~ -1 , t_ max were ( 1.17 ± 0.67) h and (1.27 ± 0.73) h, AUC_ 0-12 were (637.63 ± 379.83 ) ng·h·mL~ -1 and (591.05 ± 300.77) ng·h·mL~ -1 , respectively. As to these parameters, the analysis of variance (ANOVA) showed no significant difference.Conclusion The test formulation was considered bioequivalent to the reference formulations.
Publication Year: 2006
Publication Date: 2006-01-01
Language: en
Type: article
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Cited By Count: 2
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