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클래리스로마애신 정제의 생물학적 동등성 평가
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저자명
김종국,이사원,최하곤,고종호,이미경,김인숙
간행물명
The journal of applied pharmacology : the official journal of the Korean Society of Applied Pharmacology
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1998년|6권 2호|pp.219-224 (6 pages)
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한국응용약물학회
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이 논문은 한국과학기술정보연구원과 논문 연계를 통해 무료로 제공되는 원문입니다.
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기타언어초록

The bioequivalence of two clarithromvcin products was evaluated with 16 normal male volunteers (age 23-28 yr, body weight 57.5-75.517g) following single oral dose. Test product was ReYon Clarithromycin tablets (ReYon Pharm. Corp., Korea) and reference product was Klarici $d_{R}$ tablets (Abbott Korea). Both products contain 250 mg of clarithromucin. One tablet of the test or the reference product was administered to the volunteers, respectively, by randomized two period cross-over study (2$ imes$2 Latin square method). The determination of clarithromycin was accomplished using a modified agar well diffusion bioassay. As a result of the assay validation, the quantification of clarithromycin in human serum by this technique was possible down to 0.03$mu$g/ml using 100$mu$l of serum. The coefficient of variation (C.V.) was less than 10%. Average drug concentrations at each sampling time and pharmacokinetic parameters calculated were not significantly different between two products P>0.05); the area under the curve to last sampling time (24 hr) (AU $Co_{24hr}$ (8.10$pm$ 1.26 vs 8.22$pm$ 1.627g . hr/ml), AUC from time zero to infinite (AU $Co_{infty}$) (8.61 $pm$ 1.28 vs 8.84$pm$ 1.71 $mu$g . hr/ml), maximum plasma concentration ( $C_{msx}$) (0.87$pm$0.22 vs 0.88$pm$0.19 $mu$g/ml) and time to maximum plasma concentration ( $T_{max}$) (2.69 $pm$0.48 vs 2.56$pm$ 0.51 hr). The differences of mean AU $Co_{24h}$, $C_{msx}$ and $T_{msx}$ between the two products (1.44, 1.39, and 4.65%, respectively) were less than 20%. The power (1-$eta$) and treatment difference ($Delta$) for AU $Co_{24hr}$, and $C_{max}$ were more than 0.8 and less than 0.2, respectivly. Although the power for $T_{max}$ was under 0.8, $T_{max}$. of the two products was not significantly different each other (p>0.05). These results suggest that the bioavailability of ReYon Clarithromycin tablets is not significantly different from that of Klarici $d_{R}$ tablets. Therefore, two products are bioequivalent based on the current results. results.sults.sults.s.s.s.s.s.s.s.