Studies on pharmacokinetics and relative bioavailability of two kinds of lovastain tablets
Chunjie Zhao
Abstract
Chunjie Zhao
Abstract
Objective:To evaluate the bioequivalence of two kinds of lovastain tablets.Methods:The randomized, crossed-over study was conducted in 18 healthy volunteers.After a single dose(containing 100 mg lovastain),the plasma drug levels were determined by HPLC.The concentration-time curve,C_(max),T_(max),were compared by statisti- cal analysis.Results:The main pharmaeokinetic parameters of test and reference preparation were as followed:t_(max) (h)were 2.11±0.21 and 2.11±0.21,C_(max)(ng·mL~(-1))were 93.73±17.42 and 92.67±13.98,t_(1/2)(h)were 6.75±1.33and 6.50±1.09,AUC_(0-24)(ng·mL~(-1)·h~(-1))were 480.56±55.75 and 478.24±69.26.AUC_(0→∞) (ng·mL~(-1)·h~(-1))were 555.33±69.98 and 543.04±76.25.Conclusion:The results show that the two formula- tions were bioequivalent.The relative bioavailability of lovastain tablets was(102.67±6.98)%.
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Objective:To evaluate the bioequivalence of two kinds of lovastain tablets.Methods:The randomized, crossed-over study was conducted in 18 healthy volunteers.After a single dose(containing 100 mg lovastain),the plasma drug levels were determined by HPLC.The concentration-time curve,C_(max),T_(max),were compared by statisti- cal analysis.Results:The main pharmaeokinetic parameters of test and reference preparation were as followed:t_(max) (h)were 2.11±0.21 and 2.11±0.21,C_(max)(ng·mL~(-1))were 93.73±17.42 and 92.67±13.98,t_(1/2)(h)were 6.75±1.33and 6.50±1.09,AUC_(0-24)(ng·mL~(-1)·h~(-1))were 480.56±55.75 and 478.24±69.26.AUC_(0→∞) (ng·mL~(-1)·h~(-1))were 555.33±69.98 and 543.04±76.25.Conclusion:The results show that the two formula- tions were bioequivalent.The relative bioavailability of lovastain tablets was(102.67±6.98)%.
Key concepts: Bioequivalence, Bioavailability, Chemistry, Pharmacokinetics, Chromatography, Plasma concentration, High-performance liquid chromatography, Pharmacology