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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,
S., Kim,
M., Kim,
H., Kwak,
H., Min,
H., Sohn,
D., &
Hong,
Y.
(2001). Bioequivalence Evaluation of the Tiropramide Formulation by GC/MS. Analytical Science and Technology, 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<TEX>$^{(R)}$</TEX> injection (S Pharm. Co, Ltd.) and reference product was Tiropa<TEX>$^{(R)}$</TEX> 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 <TEX>${\alpha}
- keywords
- tiropramide, GC/MS, bioequivalence
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