Abstract
To evaluate the pharmacokinetics and relative bioavailability of two allopurinol tablets in healthy Chinese volunteers. A single-center, randomized, cross-over, two-period study design was conducted in healthy male subjects who were identified as not carrying the HLA-B*58:01 allele. Under fasting conditions, a single oral dose of 300mg test or reference tablets was given with a 1-week washout period. The blood samples were collected for up to 12hours after the administration and the plasma concentrations of allopurinol were determined by high performance liquid chromatography. Subject interviews and physical examinations were done over regular intervals to monitor the adverse events. 18 subjects were enrolled in the study, and none dropped out. The main pharmacokinetic parameters of allopurinol test and reference preparations were as follows: AUC<sub>0-tlast</sub> was 6,725.1 ± 1,390.0 ng×h×mL<sup>-1</sup> and 6,425.6 ± 1,257.6 ng×h×mL<sup>-1</sup>; AUC<sub>0-∞</sub> was 7,069.1 ± 1,503.2 ng×h×mL<sup>-1</sup> and 6,750.6 ± 1,347.7 ng×h×mL<sup>-1</sup>; t<sub>max</sub> was 1.3 ± 0.8hours and 1.3 ± 0.8hours; C<sub>max</sub> was 2,203.7 ± 557.4 ng×mL<sup>-1</sup> and 2,310.8 ± 662.8 ng×mL<sup>-1</sup>; and T<sub>1/2</sub> was 2.0 ± 1.6hours and 1.7 ± 0.7hours. The relative bioavailability was 105.1 ± 12.6%. The 90% confidence intervals for the geometric mean ratios (test/reference) of C<sub>max</sub>, AUC<sub>0-tlast</sub>, and AUC<sub>0-∞</sub> of both preparations fell within the bioequivalence acceptance criteria (80-125%). No adverse events were found or reported during the study. The test allopurinol preparations and the reference preparations are bioequivalent and both are well tolerated. .
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
More From: International journal of clinical pharmacology and therapeutics
Disclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.