Pharmacokinetics of anastrozole in Chinese male volunteers

AIM: To compare pharmacokinetics of domestic and imported tablets of anastr ozole. METHODS: Twenty male Chinese volunteers were enrolled in a randomize d crossover study with a single oral dose of 1 mg of the two formulations r espectively. The anastrozole in plasma was measured by gas chromatography w ith electron-captured detector. Area under the drug concentration-time curv e was evaluated by variance analysis and two one-side t-test. RESULTS: A tw o-compartment model was adopted in anastrozole plasma concentration-time da ta analysis. The paramaters such as C-max T-max, T-1/2 beta, and AUC(0-infi nity) were (10 +/- 3) and (10.2 +/- 2.5) mug .L-1 (1.2 +/- 0.5) and (1.3 +/ - 0.4) h, (42 +/- 14) and (41 +/- 26) h, (443 +/- 141) and (429 +/- 121) mu g .h .L-1, respectively, and there were no significant differences between the two formulations. CONCLUSION: Domestic and imported anastrozole were of bioequivalence. The relative bioavailability of the domestic tablet was 10 0 % +/- 9 %.