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Chinese Journal of Clinical Pharmacology and Therapeutics ›› 2006, Vol. 11 ›› Issue (7): 771-775.

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Bioequivalence study of ranitidine caps in healthy volunteers

CHEN Lei, YANG Jing1, ZHOUMei1, YU Feng, WANG Guang-ji1   

  1. Department of Pharmacology, Key Laboratory of Drug Metabolism and Pharmacokinetics, Pharmacy Faculty of China Pharmaceutical University , Nanjing 210009 , Jiangsu, China
  • Received:2006-03-27 Revised:2006-04-27 Online:2006-07-26 Published:2020-10-30

Abstract: AIM: To study the pharmacokinetic activities and bioequivalence of ranitidine capsule after oral administration in healthy volunteers.METHODS: A single administration of 300 mg test and reference ranitidine were given to 20 healthy male volunteers in randomized crossover study respectively.The HPLC was developed to determine the concentration of ranitidine in human plasma.RESULTS: The pharmacokinetics parameters after a single oral dministration of 300 mg test and reference products were as follows:Cmax were 1.62±0.56 and 1.78±0.69 μg·ml-1, t max were 2.8±1.1 and 2.6±0.8 h, AUC0-τ were 6.69±1.46 and 6.67±1.86μg·h·ml-1 , AUC0-∞ were 7.06±1.56 and 7.06±1.86 μg·h·ml-1 , respectively.The relative bioavailability of single oral administration group was 103.8 %±19.1 %.CONCLUSION: The test and reference products were bioequivalent.

Key words: ranitidine, HPLC, pharmacokinetics, average bioequivalence, population bioequivalence, micropillets capsules

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