2000•Journal of Pediatric PharmacyRequires access

Bioequivalent study of two Famotidine preparations

Cheng Dzeguang

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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.

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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.

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Available 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.

Key concepts: Famotidine, Bioequivalence, Bioavailability, Cmax, Pharmacokinetics, Medicine, Pharmacology

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