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Arzneimittelforschung 2008; 58(11): 581-584
DOI: 10.1055/s-0031-1296560
Antiemetics · Gastrointestinal Drugs · Urologic Drugs
Editio Cantor Verlag Aulendorf (Germany)

Clinical Study on the Influence of a Fixed-dose Combination of Famotidine with Calcium Carbonate and Magnesium Hydroxide on the Bioavailability of Famotidine

Qing Zhai
1   State base for drug clinical trial, Ruijing Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, The People’s Republic of China
,
Jun Fu
*   Present address: Department of Pharmacy, Shanghai Tenth Hospital, Shanghai, The People’s Republic of China
,
Xia Huang
1   State base for drug clinical trial, Ruijing Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, The People’s Republic of China
,
Bin Xu
1   State base for drug clinical trial, Ruijing Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, The People’s Republic of China
,
Yao-Zong Yuan
1   State base for drug clinical trial, Ruijing Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, The People’s Republic of China
,
Tao Jiang
1   State base for drug clinical trial, Ruijing Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, The People’s Republic of China
,
Zheng-Xing Rong
1   State base for drug clinical trial, Ruijing Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, The People’s Republic of China
,
Hong-Zhuan Chen
1   State base for drug clinical trial, Ruijing Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, The People’s Republic of China
› Author Affiliations
Further Information

Publication History

Publication Date:
19 December 2011 (online)

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Abstract

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 (Cmax) and area under the curve (AUC0–t) of famotidine 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.

Key words

Antacids - Calcium carbonate, fixed dose combination, interaction with famotidine - CAS 76824-35-6 - Famotidine, bioavailability, fixed dose combination, pharmacokinetics - Histamine H2-receptor antagonists - Magnesium hydroxide, fixed dose combination, interaction with famotidine
 

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