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명승운(Seung Woon Myung),김동현(Dong Hyun Kim),김명수(Myung Soo Kim),강태경(Tae Kyeong Kang),민혜기(Hye Ki Min),장윤정(Yoon Jung Jang),손동렬(Dong Ryul Sohn),홍영훈(Young Hun Hong),신창식(Chang Shik Shin) 한국응용약물학회 2000 Biomolecules & Therapeutics(구 응용약물학회지) Vol.8 No.3
The bioequivalence of two tiropramide products was evaluated in 18 health male volunteers following oral administration. Test product was Tiram^R tablet (Shin Poong SP-102) (Shin Poong Pharm. Co., Ltd.) and reference product was Tiropa^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 X 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 α=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.