Clinical study on the influence of a fixed-dose combination of famotidine with calcium carbonate and magnesium hydroxide on the bioavailability of famotidine.
The potential interaction of the H2-receptor antagonist famotidine (CAS 76824-35-6) with calcium carbonate (CAS 471-34-1) and magnesium hydroxide (CAS 1309-42-8) during administration of the famotidine fixed dose combination (FDC) formulation was investigated. A randomized, open-label, two-period, crossover study was carried out on 12 healthy Chinese volunteers. Plasma concentration-time profiles of famotidine were similar with the FDC formulation and common formulation. Confidence interval (90% CI) for maximal concentration (C(max)) and area under the curve (AUC(o-t)) of famoti-dine were 94.8-112.2% and 94.2-112.3%, respectively. These findings suggest that calcium carbonate/magnesium hydroxide antacids have no significant effects on famotidine pharmacokinetics when they are administered together with famotidine as an FDC formulation.
Zhai
Qing
Q
Ruijing Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, The People's Republic of China.
Fu
Jun
J
Huang
Xia
X
Xu
Bin
B
Yuan
Yao-Zong
YZ
Jiang
Tao
T
Rong
Zheng-Xing
ZX
Chen
Hong-Zhuan
HZ
D000328:Adult; D019540:Area Under Curve; D001682:Biological Availability; D002119:Calcium Carbonate / Q000008:administration & dosage* / Q000493:pharmacokinetics* / Q000494:pharmacology*; D002626:Chemistry, Pharmaceutical; D018592:Cross-Over Studies; D004311:Double-Blind Method; D004338:Drug Combinations; D015738:Famotidine / Q000008:administration & dosage* / Q000493:pharmacokinetics*; D005260:Female; D006633:Histamine Antagonists / Q000008:administration & dosage* / Q000493:pharmacokinetics*; D006801:Humans; D008276:Magnesium Hydroxide / Q000008:administration & dosage* / Q000494:pharmacology*; D008297:Male; D013607:Tablets
D004338:Drug Combinations; D006633:Histamine Antagonists; D013607:Tablets; D015738:Famotidine; D002119:Calcium Carbonate; D008276:Magnesium Hydroxide