Determination of relative bioavailability of anastrozole in healthy volunteers / 中国新药与临床杂志

ABSTRACT

AIM: To evaluate the bioequivalence of domestic and imported anastrozole tablet. 　METHODS: According to the crossover design, each volunteer was orally given anastrozole tablets (1 mg). GC determined the drug concertrations in plasma. The linear ranges was from 0.5 to 200.0 μg*L-1 plasma (r=0.9997, n=9). The recovery rates of lower, mid, higher concentration (1.0,10.0,20.0 μg*L-1 plasma were 93.50 %, 100.17 %,98.96 % respectively. Inter-day and intra-day precisions of the method were <13 %. 　RESULTS: The pharmacokinetic parameters of the domestic and imported tablet were 1.2 h±0.5 h and 1.3 h±0.4 h for T max, 10 μg*L-1±3 μg*L-1 and 10.2 μg*L-1±2.5 μg*L-1 for Cmax, 386 μg*L-1±117 μg*L-1 and 385 μg*L-1±117 μg*h-1*L-1 for AUC0-T,36 h±14 h and 32 h±10 h for T1/2 respectively. The relative bioavailability of the domestic tablet was (100±9) %. 　CONCLUSION: Domestic and imported anastrozole tablet are bioequivalence in healthy volunteers.