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KMID : 0369820060360020137
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Jorunal of Korean Pharmaceutical Sciences
2006 Volume.36 No. 2 p.137 ~ p.142
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Bioequivalence of Daewoong Alendronate(TM) Tablet to Fosamax (TM) Tablet (Sodium Alendronate 70 mg)
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이예리/Lee YR
정선경/양승권/최기호/신용철/전형규/강승우/이희주/Jung SK/Yang SK/Choi KH/Shin YC/Jeon HG/Kang SW/Lee HJ
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Abstract
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A bioequivalence of Daewoong AlendronateTM (Daewoong Pharmaceutical Co., Ltd., Korea) and FosamaxTM tablets (MSD Korea) was evaluated according to the guideline of Korea Food and Drug Administration (KFDA). A single 70 mg dose of sodium alendronate of each medicine was administered orally to 56 healthy male volunteers. This study was performed in a 2\time2 crossover design. Concentrations of alendronate in the urine were monitored by a high-performance liquid chromatography (HPLC). Aet (cumulative urinary excreted amount from time 0 to last sampling interval) was calculated by the accumulation of the urinary excreted alendronate. Umax (maximum urinary excretion rate) and Tmax (time to reach Umax) were compiled from the urinary excretion rate - time data. Analysis of variance was performed using logarithmically transformed Aet and Umax. No significant sequence effect was found for all of the bioavailability parameters. The 90% confidence intervals of the Aet and Umax for Daewoong AlendronateTM/FosamaxTM were 0.89-1.12 and 0.82-1.02, respectively. This study demonstrated the bioequivalence of Daewoong AlendronateTM and FosamaxTM with respect to the rate and extent of absorption.
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KEYWORD
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Sodium alendronate, Daewoong Alendronate(TM), Fosamax(TM), Bioequivalence, HPLC
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