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Chinese Journal of Clinical Pharmacology and Therapeutics ›› 2000, Vol. 5 ›› Issue (3): 245-247.

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Bioequivalence of domestic nimodipine capsules and toblets

ZHANG Hong, FU Jun, DAI Qun, LI Yan-Yan, XIONG Yu-Qing   

  1. Institute of Clinical Pharmacology,Jiangxi Medical College,Nanchang,330006
  • Received:2000-05-04 Revised:2000-05-26 Online:2000-09-26 Published:2020-11-25

Abstract: Aim The bioequivalence of domestic nimodipine capsules and tablets in healthy volunteers was compared.Methods A single oral dose of capsule or tablet of 100 mg nimodipine was given to 18 healthy volunteers in a randomized crossover study.Plasma levels of the drue were determined with HPLC method.Results The plasma concentration-time curve fitted to the first order absorption,1-compartment open model.Their main pharmacoknietic parameters were Cmax (56.4±16.9)μg·L-1,t1/2(ke) (2.08±0.42)h,tpeak (1.27±0.52) h ,AUC0~9 (197.2±46.5)μg ·h-1·L-1.These was no statistically significant difference between the two products (P>0.05).The relative bioavailability of tested capsules to reference tablets was (99.3±13.1)%.Conclusion Both formulations are of bioequivalence.

Key words: nimodipine, HPLC, bioequivalence

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