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KMID : 0369820070370010057
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Jorunal of Korean Pharmaceutical Sciences
2007 Volume.37 No. 1 p.57 ~ p.62
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Bioequivalence of DonpezilTM Tablet to AriceptTM Tablet (Donepezil Hydrochloride 10 mg)
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Lee Hyun-Soo
Seo Ji-Hyung
Kang Il-Mo
Lee Heon-Woo
Ryu Ju-Hee
Lee Kyung-Tae
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Abstract
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The purpose of the present study was to evaluate the bioequivalence of two donepezil tablets, AriceptTM tab- let (Dae Woong Pharm. Co. . Ltd. , Korea, reference drug) and DonpezilTM tablet (Dong Wha Pharm. Ind. Co. , Ltd. , Korea, test drug), according to the guidelines of Korea Food and Drug Administration (KFDA). Twenty-four healthy male Korean volunteers received one tablet containing donepezil hydorchloride 10 mg in a 2×2 crossover study. There was three-week washout period between the doses. Plasma concentrations of donepezil were monitored by an LC-MS/MS for over a period of 240 hr after the administration. AUCt (the area under the plasma concentration-time curve from time zer to 240 hr) was calculated by the linear trapezoidal rule method. Cmax (maximum plasma drug concentration) and Tmax (time to reach Cmax) were compiled from the plasma concentration-time data. Analysis of variance was carried out using logarithmically trans- formed AUCt and Ct. No significant sequence effects were found for all of the bioavailability parameters indicting that the crossover design was properly performed. The 90% confidence intervals of the AUCt and Cmax were log0.95~log1.03 and log0.94~log1.08, respectively. These values were within the acceptable bioequivalence intervals of log0.80~log1.25. Taken together, our study demonstrated the bioequivalence of AriceptTM and DonpezilTM with respect to the rate and extent of absorption.
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KEYWORD
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Donpezil, LC-MS/MS, Bioequivalence
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