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KMID : 0369820060360030193
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Jorunal of Korean Pharmaceutical Sciences
2006 Volume.36 No. 3 p.193 ~ p.199
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Bioequivalence of Sudo(TM) Ranitidine Hydrochloride Tablet to Curan(TM) Tablet (Ranitidine Hydrochloride 150 ㎎)
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이선녀/Lee SN
고연정/강승우/윤서현/박무신/이예리/이경률/이희주/Ko YJ/Kang SW/Yoon SH/Park MS/Lee YR/Lee KR/Lee HJ
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Abstract
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A bioequivalence study of SudoTM Ranitidine HCI tablet (Sudo Pharma. Ind. Co., Ltd.) to CuranTM tablet (Il Dong Pharma. Ind. Co., Ltd.) was conducted according to the guidelines of Korea Food and Drug Administration (KFDA). Twenty four healthy male Korean volunteers received each medicine at the ranitidine hydrochloride dose of 150 mg in a 2x2 crossover study. There was a one week wash-out period between the doses. Plasma concentrations of ranitidine were monitored by a high-turbulent liquid chromatography (HTLC) for over a period of 12 hours after drug administration. AUCt (the area under the plasma concentration-time curve from time zero to 12 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 transformed AUCt and Cmax. No significant sequence effect was found far all of the bioavailability parameters indicating that the crossover design was properly performed. The 90% confidence intervals of the AUCt ratio and the Cmax ratio for SudoTM Ranitidine HCl/CuranTM were 0.92-1.00 and 0.90-1.03, respectively. These values were within the acceptable bioequivalence intervals of 0.80-1.25. Thus, our study demonstrated the bioequivalence of SudoTM Ranitidine HCI and CuranTM with respect to the rate and extent of absorption.
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KEYWORD
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Ranitidine, Curan(TM), Sudo(TM) Ranitidine HCl, Bioequivalence, HTLC
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