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The clinical pharmacokinetics of osmotic pump controlled release tablets of terazosin hydrochloride in healthy volunteers

Ting-Sheng Ma*, Gao Li, Guang-Zhong Yang, Zhi-Hua Liu, Lan-Cun Zhu   

  1. 1. Pharmacology Department of Huaihua Medical College, Huaihua, Hunan 418000, China
    2. Tongji Medical College of Huazhong University of Science and Technology, Wuhan 430030, China
    3. Pharmacology Department of South-Central University for Nationalities, Wuhan 430074, China
  • Received:2010-12-01 Revised:2011-03-20 Online:2011-05-06 Published:2011-05-06
  • Contact: Ting-Sheng Ma*

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Abstract:

The clinical pharmacokinetics of osmotic pump controlled release tablets of terazosin hydrochloride in healthy volunteers was studied. A sensitive and rapid HPLC method was used to determine the terazosin plasma concentrations, and single and multiple doses of terazosin hydrochloride regular tablets (reference tablets) and osmotic pump controlled release tablets were orally administrated in randomized crossover design. The results showed that the Cmax of the reference tablets after single oral dose ((120.56±23.15) ng/mL) in 20 healthy volunteers was significantly higher than that of controlled release tablets ((95.27±16.35) ng/mL). The Tmax of the controlled release tablets ((2.65±0.82) h) was significantly longer than that of reference tablets ((1.27±0.61) h) (P<0.05). The relative bioavailability of the controlled release tablets was found to be (105.85±6.12)%. The multiple oral dose pharmacokinetic parameters of the regular tablets and controlled release tablets were as follows: AUCss were (1275.17±175.35) and (1382.65±205.31) ng·h/mL respectively, Cmax were (128.15±22.37) and (98.57±18.16) ng/mL respectively, Tmax were (1.35±0.71) and (2.76±0.85) h respectively, Cav were (53.13±9.12) and (57.61±9.25) ng/mL respectively, and DF were (2.25±0.26)% and (1.62±0.25)% respectively. The relative bioavailability of the controlled release tablets to the reference tablets was (108.43±6.26)%. The controlled release tablet of terazosin hydrochloride was bioequivalent to the reference tablet. The controlled release tablet exhibited a sustained-release property with a significantly longer Tmax and lower Cmax.

Key words: Terazosin hydrochloride, Osmotic pump system, Controlled release tablets, Pharmacokinetics, Bioequivalence

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