Studies on bioequivalence of two nimodipine tablets in healthy volunteers by HPLC-MS
Zou Jiang-jun
Abstract
Zou Jiang-jun
Abstract
OBJECTIVE To evaluate the bioequivalence of two domestic nimodipine tablets.METHODS A single oral administration of 60mg nimodipine tablet was given to 20 healthy volunteers.Nimodipine concentrations in plasma were determined by HPLC-MS.RESULTS The main pharmacokinetic parameters of two nimodipine tablets were as follow:t1/2 was(2.1±0.3) and(2.2±0.4)h,tmax was(1.5±0.4) and(1.6±0.4)h,cmax was(28.21±7.12) and(28.79±7.56)ng·mL-1,AUC was(105.88±29.49) and(106.46±26.38)μg·h·L-1,respectively.The relative bioavailability of the test tablet was 99.4±5.3%。CONCLUSION The results demonstrated that the two tablets were bioequivalent.
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OBJECTIVE To evaluate the bioequivalence of two domestic nimodipine tablets.METHODS A single oral administration of 60mg nimodipine tablet was given to 20 healthy volunteers.Nimodipine concentrations in plasma were determined by HPLC-MS.RESULTS The main pharmacokinetic parameters of two nimodipine tablets were as follow:t1/2 was(2.1±0.3) and(2.2±0.4)h,tmax was(1.5±0.4) and(1.6±0.4)h,cmax was(28.21±7.12) and(28.79±7.56)ng·mL-1,AUC was(105.88±29.49) and(106.46±26.38)μg·h·L-1,respectively.The relative bioavailability of the test tablet was 99.4±5.3%。CONCLUSION The results demonstrated that the two tablets were bioequivalent.
Key concepts: Bioequivalence, Nimodipine, Cmax, Bioavailability, Pharmacokinetics, Pharmacology, High-performance liquid chromatography, Medicine