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Chinese Journal of Clinical Pharmacology and Therapeutics ›› 2004, Vol. 9 ›› Issue (11): 1305-1308.

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Research on bioequivalence of flunarizine hydrochloride dispersible tablets in healthy volunteers

ZHAO Yan, LIU Zhen-Sheng, LI Zhi-Ping, ZHAO Mei-Ling1, QI Fang-Mei2, WANG Shao-Hua   

  1. Base For Drug Clinical Trial, 1Department of Health Care, 2Department of Osorhinolaryngology, Qingdao Municipal Hospital,Qingdao 266011, Shangdnng, China
  • Received:2004-07-09 Revised:2004-11-08 Online:2004-11-26 Published:2020-11-19

Abstract: AIM: To study the bioequivalence be-tween flunarizine hydrochloride dispersible tablets and capsules in healthy volunteers. METHODS: A single dose of 20 mg flunarizine hydrochloride dispersible tablets and capsules were given to 20 healthy volunteers by a ran-domized,two way cross-over design. Plasma concentra-tions of flunarizine hydrochloride were determined by HPLC. RESULTS: The pharmacokinetic parameters after administration of flunarizine hydrochloride dispersible tablets and contrast flunarizine hydrochloride capsules (20 mg) were as follows: AUC0-1, 424.27±74.01 and 410.25±72.56 μg·L-1,C_67.02±14.89 and 67.45±15.68 μg·L-1,Tmax 2.90±0.42 and 2.98±0.47 h, and t1/2ke9.73±3.15 and 8.89±3.08 h,respectively. The relative bioavailability of the flunaiizine hydrochloride tablets was (104.12±12.23)%. CONCLUSION: Two formations of flunarizine hydrochloride are bioequivalent.

Key words: flunarizine hydrochloride, HPLC, phar-macokinetics, bioavailability, dispersible tablets

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