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Studies on human pharmacokinetics and relative bioequivalence of lisinopril tablets

Chunjie Zhao

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Abstract

Objective:To evaluate the bioequivalence of national and imported lisinopril tablets.Methods:The ran- domized,crossed-over study was conducted in 18 healthy volunteers.After a single dose(containing 20 mg lisino- pril),the drug levels in plasma were determined by HPLC.Results:The main pharmacokinetics parameters of test and reference preparation were as followed:t_(max)were(6.00±0.00)h and(6.11±0.47)h,C_(max)were(110.37± 23.35)ng·mL~(-1)and(109.18±26.06)ng·mL~(-1),t_(1/2)were(16.20±2.10)h and(16.50±2.28)h,AUC_(0-60) were(1531.73±239.08)μg·mL~(-1)·h and(1535.39±170.93)μg·mL~(-1)·h.Conclusion:The results show that the two formulations are bioequivalent.The relative bioavailability of lisinopril tablets is(99.8±10.7)%.

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Objective:To evaluate the bioequivalence of national and imported lisinopril tablets.Methods:The ran- domized,crossed-over study was conducted in 18 healthy volunteers.After a single dose(containing 20 mg lisino- pril),the drug levels in plasma were determined by HPLC.Results:The main pharmacokinetics parameters of test and reference preparation were as followed:t_(max)were(6.00±0.00)h and(6.11±0.47)h,C_(max)were(110.37± 23.35)ng·mL~(-1)and(109.18±26.06)ng·mL~(-1),t_(1/2)were(16.20±2.10)h and(16.50±2.28)h,AUC_(0-60) were(1531.73±239.08)μg·mL~(-1)·h and(1535.39±170.93)μg·mL~(-1)·h.Conclusion:The results show that the two formulations are bioequivalent.The relative bioavailability of lisinopril tablets is(99.8±10.7)%.

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Available abstract

Objective:To evaluate the bioequivalence of national and imported lisinopril tablets.Methods:The ran- domized,crossed-over study was conducted in 18 healthy volunteers.After a single dose(containing 20 mg lisino- pril),the drug levels in plasma were determined by HPLC.Results:The main pharmacokinetics parameters of test and reference preparation were as followed:t_(max)were(6.00±0.00)h and(6.11±0.47)h,C_(max)were(110.37± 23.35)ng·mL~(-1)and(109.18±26.06)ng·mL~(-1),t_(1/2)were(16.20±2.10)h and(16.50±2.28)h,AUC_(0-60) were(1531.73±239.08)μg·mL~(-1)·h and(1535.39±170.93)μg·mL~(-1)·h.Conclusion:The results show that the two formulations are bioequivalent.The relative bioavailability of lisinopril tablets is(99.8±10.7)%.

Key concepts: Bioequivalence, Lisinopril, Chemistry, Pharmacokinetics, Bioavailability, Chromatography, Pharmacology, Human plasma

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