School of Pharmacy, Sichuan University,Chengdu 610041,China
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History+
Received
Published
2007-12-18
2008-11-10
Issue Date
2008-11-10
Abstract
OBJECTIVE To investigate the pharmacokinetics of compound famotidine chewing tablets in healthy volunteers and to establish the clinical prescription.METHODS The plasma concentrations of famotidine for single dosage oral administration without meal(low,middle and high dosage,they contained 20,30 and 40 mg famotidine) and with meal as well as multiple doses were examined.RESULTS The AUC0→12 of single dosage oral administration were(243.39±41.10),(347.05±25.95) and(516.12±55.37)μg·h·L-1 respectively,peak time(tmax) were(2.96±0.33),(2.50±0.30) and(2.63±0.38)h,plasma peak concentration(ρmax) were(67.10±5.71),(94.18±3.21) and(125.43±5.30)μg·L-1,elimination rate constants(k) were(0.18±0.02),(0.17±0.02) and(0.19±0.04)h-1,elimination half-life time(t1/2) were(3.85±0.52),(4.12±0.59) and(3.85±0.77)h.For low dosage of oral administration after meal,the AUC0→12 of famotidine was(257.94±39.88)μg·h·L-1,tmax was(2.83±0.39)h,ρmax was(64.56±2.18)μg·L-1,k was(0.20±0.04)h-1,t1/2 was(3.54±0.69)h.For multiple dosage administration after steady state,the AUC0→τof famotidine was(310.02±23.95)μg·h·L-1,tmax was(2.46±0.33)h,steady state trough plasma concentration(ρSSmin) was(7.84±1.31)μg·L-1 and peak plasma concentration(ρSSmax) was(60.78±2.13)μg·L-1 respectively,average plasma concentration(ρSS) after steady state was(25.83±2.00)μg·L-1,k was(0.20±0.03)h-1,t1/2 was(3.61±0.54)h,degree of fluctuation(DF) was 2.06,accumulation index was 0.02.CONCLUSION q-test was performed on the ratio of AUC0→12 to dose of low,middle and high dosage oral administration without meal.The pharmacokinetics of compound famotidine chewing tablets in vivo accorded with linear process.Variance test was performed on pharmacokinetic parameters of administration without and with meal.Food had no effect on pharmacokinetics of famotidine in vivo.The multiple administration showed no accumulation in vivo.
ZHOU Jing;WNG Ling;YNG Jun-yi;LN Ke;JING Xue-hu.
Clinical Pharmacokinetics of Compound Famotidine Chewing Tablets [J]. Chinese Pharmaceutical Journal, 2008, 43(22): 1730-1734
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References
[1] CUI X Y,GU S F,CHEN X Y,et al.Pharmacokinetics of compound famotidine chewable tabletsin Chinese healthy volunteers[J] .Chin Hosp Pharm J(中国医院药学杂志),2006,26(10):1215-1218.
[2] LIU B L,ZHANG W B,SHEN Y X,et al. The evaluation of pharmacokinetics and bioequivalence of famotidine powder and tablets[J] .Academic J of Sec Military Medical Univ(第二军医大学学报),1999,20(4):250-254.