Bioequivalence of Terazosin Hydrochloride Tablets in Healthy Volunteers
【Abstract】OBJECTIVE To evaluate the bioequivalence of test and reference preparations of Terazosin Hydrochloride Tablets in healthy male volunteers. METHODS This is an open random and two-way crossover clinical trial involved 18 healthy male subjects. The volunteers were randomly divided into two groups. They were given a single oral dose of test and reference preparations of Terazosin Hydrochloride Tablets (2 mg for each). 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 preparations were as follows: the median (min, max) of tmax was 1.00 (0.25, 2.00) h and 0.75 (0.50, 4.00) h; ρmax was (49.72 ± 9.86) and (61.66 ± 18.37) ng·mL−1; AUC0-t was (516.35 ± 107.33) and (616.58 ± 118.48) ng·h·mL−1; AUC0-∞ was (532.62 ± 112.42) and (634.99 ± 122.49) ng·h·mL−1; the relative bioavailability of the test preparation was (100.17 ± 13.92)%; 90% CI of AUC0-t and ρmax of the test preparation was 93.8%–105.1% and 88.3%–108.4%. No serious adverse events were observed during the trials. CONCLUSION Two kinds of Terazosin Hydrochloride Tablets are bioequivalent.
【Keywords】 terazosin; fast; bioequivalence; LC-MS/MS; pharmacokinetics;
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