Pharmacokinetics of anastrozole in Chinese male volunteers
Abstract
Aim: To compare pharmacokinetics of domestic and imported tablets of anastrozole.
Methods: Twenty male Chinese volunteers were enrolled in a randomized crossover study with a single oral dose of 1 mg of the two formulations respectively. The anastrozole in plasma was measured by gas chromatography with electron-captured detector. Area under the drug concentration-time curve was evaluated by variance analysis and two one-side t-test.
Results: A two-compartment model was adopted in anastrozole plasma concentration-time data analysis. The paramaters such as Cmax, Tmax, T1/2beta, and AUC(0-infinity) were (10 +/- 3) and (10.2 +/- 2.5) microg/L, (1.2 +/- 0.5) and (1.3 +/- 0.4) h, (42 +/- 14) and (41 +/- 26) h, (443 +/- 141) and (429 +/- 121) microg . 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 100 % +/- 9 %.
Keywords:
Methods: Twenty male Chinese volunteers were enrolled in a randomized crossover study with a single oral dose of 1 mg of the two formulations respectively. The anastrozole in plasma was measured by gas chromatography with electron-captured detector. Area under the drug concentration-time curve was evaluated by variance analysis and two one-side t-test.
Results: A two-compartment model was adopted in anastrozole plasma concentration-time data analysis. The paramaters such as Cmax, Tmax, T1/2beta, and AUC(0-infinity) were (10 +/- 3) and (10.2 +/- 2.5) microg/L, (1.2 +/- 0.5) and (1.3 +/- 0.4) h, (42 +/- 14) and (41 +/- 26) h, (443 +/- 141) and (429 +/- 121) microg . 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 100 % +/- 9 %.