Bioequivalence Evaluation of the Tiropramide Formulation by GC/MS

Myung, Seung-Woon; 명승운; Kim, Myungsoo; 김명수; Kim, Hye-Young; 김혜영; Kwak, Hyun-Tae; 곽현태; Min, Hye-Ki; 민혜기; Sohn, Dong-Ryul; 손동렬; Hong, Young-Hun; 홍영훈

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P-ISSN1225-0163
E-ISSN2288-8985
SCOPUS, ESCI, KCI

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P-ISSN 1225-0163
E-ISSN 2288-8985

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Vol.14, No.3

PubReader Citation

Bioequivalence Evaluation of the Tiropramide Formulation by GC/MS

Analytical Science and Technology / Analytical Science and Technology, (P)1225-0163; (E)2288-8985

2001, v.14 no.3, pp.221-229

Myung, Seung-Woon
Kim, Myungsoo
Kim, Hye-Young
Kwak, Hyun-Tae
Min, Hye-Ki
Sohn, Dong-Ryul
Hong, Young-Hun

Myung, S., Kim, M., Kim, H., Kwak, H., Min, H., Sohn, D., & Hong, Y. (2001). Bioequivalence Evaluation of the Tiropramide Formulation by GC/MS. , 14(3), 221-229.

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Abstract

The bioequivalence study of two tiropramide products was evaluated in 16 health male volunteers following intra-muscular injection. Test product was Tiram$^{(R)}$ injection (S Pharm. Co, Ltd.) and reference product was Tiropa$^{(R)}$ injection(D Pharm. Co., Ltd.). The drug concentration in plasma was determined by GC/MS for over a period of 8 hours after injection. 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 0.73, -1.385 and -12.994%, respectively. Minimum detectable differences (%) at ${\alpha}