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KMID : 0948320070070010035
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Konyang Medical Journal
2007 Volume.7 No. 1 p.35 ~ p.43
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Comparative Bioavailability of Two Famotidine Tablet Formulations in Human Volunteers
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Cho Seong-Wan
Kim Young-Il
Kim Kwang-Hyun
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Abstract
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The bioavailability was conducted on 24 healthy volunteers who received a single dose 20 mg of each drug in the fasting state, in a randomized balanced 2 way crossover design. After dosing, serial blood samples were collected for a period of 24 hours. Plasma was analyzed for famotidine by LC/MS/MS assay. AUCt, (the area under the plasma concentration-time curve from time zero to 24 hr) was calculated by the trapezoidal rule method. Cmax (maximum plasma drug concentration) and Tmax (time to reach Cmax) were compiled from the plasma famotidine concentration- time data of each volunteer. No significant sequence effect was found for the bioavailability parameters indicating that the crossover design was properly performed. The 90% Confidence intervals of the AUCt ratio and the Cmax were log 0.9625-log 1.0940 and log 0.9402-log 1.0871, respectively. These values were within the acceptable bioequivalence intervals of 0.80-1.25. Thus, our study demonstrated that two formulations have bioequivalence with respect to the rate and extent of absorption.
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KEYWORD
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Famotidine, Bioavailability, Healthy Volunteer, Bioequivalence
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