Pharmacokinetics of anastrozole in Chinese male volunteers.
OBJECTIVE
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.


CONCLUSIONS
Domestic and imported anastrozole were of bioequivalence. The relative bioavailability of the domestic tablet was 100 % +/- 9 %.
Yuan
J
J
Base for Drug Clinical Trial of SDA, Department of Clinical Pharmacology and Pharmacy, Renji Hospital, Shanghai Second Medical University, Shanghai 200001, China yuan_jing88@hotmail.com
Wang
P Q
PQ
Ge
S R
SR
An
F R
FR
Shi
A G
AG
Chen
J
J
Liang
J Y
JY
D000328:Adult; D000077384:Anastrozole; D019540:Area Under Curve; D001682:Biological Availability; D018592:Cross-Over Studies; D006801:Humans; D008297:Male; D009570:Nitriles / Q000493:pharmacokinetics*; D014018:Tissue Distribution; D014230:Triazoles / Q000493:pharmacokinetics*
D009570:Nitriles; D014230:Triazoles; D000077384:Anastrozole