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염산티로프라미드제제의 생물학적 동등성 평가
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  • 염산티로프라미드제제의 생물학적 동등성 평가
  • Bioequivalence Evaluation of the Tiropramide hydrochloride
저자명
명승운,김동현,김명수,강태경,민혜기,장윤정,손동렬,홍영훈,신창식
간행물명
The journal of applied pharmacology : the official journal of the Korean Society of Applied Pharmacology
권/호정보
2000년|8권 3호|pp.262-268 (7 pages)
발행정보
한국응용약물학회
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이 논문은 한국과학기술정보연구원과 논문 연계를 통해 무료로 제공되는 원문입니다.
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기타언어초록

The bioequivalence of two tiropramide products was evaluated in 18 health male volunteers following oral administration. Test product was Tira $m^{R}$ tablet (Shin Poong SP-102) (Shin Poong Pharm. Co., Ltd.) and reference product was Tirop $a^{R}$ tablet (Dae Woong Pharm. Co., Ltd.) One capsule of the test and reference product containing 100 mg of tropramide.hydrochloride was administered to the volunteers by randomized two period cross-over study (2 $ imes$ 2 Latin square method). The drug concentration in plasma was determined by GC/MS for over a period of 12hours after administration. Analysis of variance reveal that there are no differences in AUC (area under the plasma concentration-time curve from time zero to infinity), Cmax (maximum plasma concentration) and Tmax (time to reach Cmax). The differences of mean AUC, Cmax and Tmax between two products were 3.85, 1.47 and -3.6%, respectively. Minimum detectable differences (%) at $alpha$=0.1 were all less than 20% given as a guideline (18.07, 17.00 and 20.69% for AUC, Cmax and Tmax, respectively). From these results, the two products are bioequivalent.ent.