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《Chinese Journal of Antibiotics》 2002-01
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Pharmacokinetics of tacrolimus, a novel potent immunsuppressant in healthy Chinese volunteers

Xu Xin-jun 1,Liu Gao-lin 2,Deng Yu-lin 2,Miao Hai-jun 2, Qian Fang 2,Zhang Zheng-xing 1andAn Deng-kui 1 (1 School of Pharmacy, China Pharmaceutical University,Nangjing 210009; 2 Division of Clinical Pharmacology, Changzhen Hospital, The Second M  
Objective: To study the pharmacokinetic profiles of tacrolimous in healthy Chinese volunteers. Methods: Eight healthy male volunteers [average age (23.5±3.85) year old, mean weight (65.69± 5.70)kg] were randomly divided into two groups, and received a single dose of tacrolimus capsule 0.1 or 0.15mg/kg respectively. Whole blood samples were determined by enzyme linked immunosorbant assay. Pharmacokinetic parameters were calculated by 3P87 software. Results: The concentration-time curves were fitted to 2-compartment model with 1st order absorption. The main pharmacokinetic parameters were as follows: T 1/2α (0.66±0.18) and (0.66±0.22)h, T 1/2β(33.87±8.01) and (32.71±17.73)h, T max (1.63±0.48) and (1.75± 0.96)h, AUC (356.9±34.82) and (535.8±317.9)ng·h/ml, CL (0.28±0.0283) and (0.33±0.018)L/(h·kg) for doses of 0.1 and 0.15mg/kg, respectively. Conclusion: After statistical analysis, no significant difference was found between the pharmacokinetic parameters [such as T 1/2α, T 1/2β, T max, CL and Ka (P0.05)] following oral two different doses, but the rate of absorption of tacrolimus and t 1/2β is variable, which was concordant with that of the references.
【CateGory Index】: R969
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