Bioequivalent study of two Famotidine preparations
Cheng Dzeguang
Abstract
Cheng Dzeguang
Abstract
The pharmacokinetics and relative bioavailability of two Famotidine preparations - dispersible tablet and tablet were studied. Famotidine was determined after a single oral dose of two Famotidine preparations were given respectively to 10 volunteers in an open randomized cross - over test. Famotidine concentration in serum was assayed by RP - HPLC method. After taking a single oral dose 40mg two Famotidine Preparations, the AUC0→∞ of Famotidine dispersible tablet and tablet were 4. 35 ± 1. 07μg/ml × h and 4. 14 ± 1. 24μg/ ml × h ;Tmax were 1. 85± 0. 34h and 1. 90 ± 0. 66h; Cmax were 0. 94 ± 0. 19μg/ml and 0. 88 ± 0. 21μg/ml respectively. The result of statistical analysis showed that there were no significant difference of the AUC0→∞、 Tmax and Cmax of Famotidine between the two formations (p 0. 05) and the two Famotidine preparations were bioequivalent.
A significance statement is not available in the OpenAlex record.
A contribution statement is not available in the OpenAlex record.
Method details are not available in the OpenAlex metadata.
Findings are not separately available in the OpenAlex metadata.
Limitations are not available in the OpenAlex metadata.
Application details are not available in the OpenAlex metadata.
The pharmacokinetics and relative bioavailability of two Famotidine preparations - dispersible tablet and tablet were studied. Famotidine was determined after a single oral dose of two Famotidine preparations were given respectively to 10 volunteers in an open randomized cross - over test. Famotidine concentration in serum was assayed by RP - HPLC method. After taking a single oral dose 40mg two Famotidine Preparations, the AUC0→∞ of Famotidine dispersible tablet and tablet were 4. 35 ± 1. 07μg/ml × h and 4. 14 ± 1. 24μg/ ml × h ;Tmax were 1. 85± 0. 34h and 1. 90 ± 0. 66h; Cmax were 0. 94 ± 0. 19μg/ml and 0. 88 ± 0. 21μg/ml respectively. The result of statistical analysis showed that there were no significant difference of the AUC0→∞、 Tmax and Cmax of Famotidine between the two formations (p 0. 05) and the two Famotidine preparations were bioequivalent.
Key concepts: Famotidine, Bioequivalence, Bioavailability, Cmax, Pharmacokinetics, Medicine, Pharmacology