Bioequivalence of Terazosin Hydrochloride Tablets in Healthy Volunteers
LIU Jian, WU Li-hua, HU Xing-jiang, WU Guo-lan, ZHOU Hui-li, SHENTU Jian-zhong*
Research Center of Clinical Pharmacy, Zhejiang Provincial Key Laboratory for Drug Evaluation and Clinical Research, State Key Laboratory for Diagnosis and Treatment of Infectious Disease, First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou 310000, China
Abstract：OBJECTIVE To evaluate the bioequivalence of test and reference preparation of terazosin hydrochloride tablets in healthy malevolunteers. METHODS This is openrandom and two-way crossover clinical trial involved 18 healthy male subjects. The volunteers were randomly divided into two groups. They were given single oral dose of test and reference preparation of terazosin hydrochloride tablets (each 2 mg). The plasma concentrations of terazosin were determined by LC-MS/MS. Pharmacokinetic parameters were obtained using DAS2.0 program. RESULTS The main pharmacokinetic parameters of terazosin hydrochloride tablets test and reference preparation were as follows:tmax were 1.00 (0.25, 2.00) h and 0.75 (0.50, 4.00)h, ρmax were and (49.72±9.86) and (61.66±18.37) ng·mL-1, AUC0-t were (516.35±107.33) and (616.58±118.48) ng·h·mL-1, AUC0-∞ were (532.62±112.42) and (634.99±122.49) ng·h·mL-1 respectively. The relative bioavailability was (100.17±13.92)%. And 90% confidence limit of test preparation of the logarithmic transformed parameters AUC0-t and ρmax were in 93.8%-105.1% and 88.3%-108.4% compared with reference preparation, respectively. No serious adverse events were observed during the trials. CONCLUSION Two kinds of terazosin hydrochloride tablets are bioequivalent.
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