Bioequivalence of terazosin hydrochloride tablets in healthy volunteers / 中国药学杂志

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.