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Chinese Journal of Clinical Pharmacology and Therapeutics ›› 2006, Vol. 11 ›› Issue (5): 558-561.

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Bioequivalence of lansoprazole enterosoluble tablets and capsules in healthy volunteers

LI Jian-chun, HU Qi-sheng1, GAO Shu1, JIANG Zhi-wen   

  1. Department of Pharmaceutics, Bengbu Medical College, Bengbu 233030, Anhui, China;
    1Heifei Heyuan Medicine.Sci-ence ﹠ Technology.Co.Ltd, Hefei 230000, Anhui, China
  • Received:2006-04-29 Revised:2006-05-20 Online:2006-05-26 Published:2020-12-09

Abstract: AIM: To investigate the bioequivalence of lansoprazole enterosoluble tablets and capsules in Chi-nese healthy volunteers.METHODS: Twenty volunteers were randomly divided into two groups (test and refer-ence), with double cross over design.The concentration of lansoprazole in serum was determined by HPLC and pharmacokinetic parameters were calculatedwith DAS 2.0 practical pharmacokinetics program.RESULTS: The pharmacokinetic parameters of lansoprazole enterosoluble tablets and capsules were as follows:t1/2 were 1.808 ± 1.031 and 1.341 ±0.498 h, Cmax were 0.764 ±0.385 and 0.902 ±0.369 μg·ml-1, Tmax were 3.639 ±0.744 and 2.500±1.000 h, AUC 0-10h were 3.024±1.941 and 3.098±1.742 μg·h·ml-1。 The relative bioavalibility of lansoprazole enterosoluble tablets was 109.57% ± 59.48%. CONCLUSION: The statistical analysis showed that the test and reference preparation were bio-equivalent.

Key words: lansoprazole, healthy human body, HPLC, bioequivalence

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