Title: Pharmacokinetics and safety of pitavastatin calcium tablets in Chinese healthy volunteers after a single oral dose administration
Abstract:Objective To investigate the pharmacokinetics and safety of single dose of pitavastatin calcium tablets in Chinese healthy volunteers.Methods Twelve volunteers were divided into three groups by 3×3 de...Objective To investigate the pharmacokinetics and safety of single dose of pitavastatin calcium tablets in Chinese healthy volunteers.Methods Twelve volunteers were divided into three groups by 3×3 design.The drug concentrations of plasma sample from the twelve volunteers after taking 1,2 and 4 mg pitavastatin calcium tablets respectively were determined by LC-MS/MS.The pharmacokinetic parameters were calculated by Das 2.0 software.Results The main pharmacokinetic parameters of pitavastatin after single oral doses(1 mg,2 mg and 4 mg)were as follows:t1/2β were(11.39 ±7.66),(10.00±7.30),(11.30±7.95)h;tmax were(0.83±0.29),(0.73±0.20),(0.85±0.46)h;Cmax were(30.48±11.66),(60.80±22.97),(120.98±35.51)ng·mL-1;AUC0→72 h were(93.19±26.61),(179.46±52.86),(364.37±94.74)ng·mL-1·h;AUC0→∞ were(96.70±27.42),(183.34±53.62),(372.86±95.84)ng·mL-1·h.The pharmacokinetic parameters such as Cmax,AUC0→72h,AUC0→ ∞ directly proportion to doses.There were no significant difference in K10,tmax,t1/2β,MRT0→72h,MRT0→ ∞,CL/F,V/F of three groups by analysis of variance.Conclusion The pharmacokinetics of pitavastatin in the dosage of 1-4 mg in human body nearly fit linear dynamic feature.The main pharmacokinetic parameters are similar to those in the reported literature.Read More
Publication Year: 2010
Publication Date: 2010-01-01
Language: en
Type: article
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