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KMID : 0869620020190010037
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Journal of Korean Society of Hospital Pharmacists
2002 Volume.19 No. 1 p.37 ~ p.42
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Bioequivalence Test of Dae Won Clarithromycin(250㎎) to Klaricid^(®) Tablets
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남기원/Nam, Ki Won
천성국/류재환/김남재/송보완/서성훈/이경태/Chun, Sung Kuk/Rew, Jae Hwan/Kim, Nam Jae/Song, Bo Wan/Seo, Seong Hoon/Lee, Kyung Tae
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Abstract
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The bioequivalence of two clarithromycin products was evaluated according to the guideline of KFDA. Test product was Dae Won Clarithromycin tablets(Dae Won Korea Ltd.) and reference product was Klaricid^(®) tablets(Abott Korea). 18 healthy male volunteers(20~28 years old) were divided into two groups and a randomized 2×2 cross-over study was employed. After 500㎎ of clarithromycin was orally administered, blood was taken at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12hours after administration and just before administration. Plasma was analyzed for clarithromycin and internal standard(erythromycin) by a sensitive and validated HPLC assay. The pharmacokinetic parameters(AUC_(t), C_(max) and T_(max)) were calculated and ANOVA test was used for the statistical analysis of parameters. Differences in AUC_(t), C_(max) and T_(max) between two products were -6.55, 3.78 and 1.44 %, respectively. The powers(1-β) and detectable differences(Δ) and confidence interval for AUC_(t), and C_(max) were more than 0.8 and less than 20%, respectively. Although the power of T_(max) was under 0.8, T_(max) of the two products were not significantly different each other. These results suggest that the bioavailability of Dae Won Clarithromycin tablets is not significantly different from that of Klaricid^(®) tablets. Therefore, two products are bioequivalent based on the current result.
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