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KMID : 0369819990290010067
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Jorunal of Korean Pharmaceutical Sciences
1999 Volume.29 No. 1 p.67 ~ p.72
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Bioequivalence of Kerora Intramuscular Injections to Tarasyn Intramuscular Injections ( Ketorolac Tromethamine 30 mg )
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정연복/Chung YB
이준섭/한건/Lee JS/Han K
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Abstract
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A bioequivalence study of the Kerola® intramuscular injections (Dongkwang Pharmaceutical Co., Korea) to the Tarasyn® intramuscular injections (Roche Co., Korea), formulations of ketorolac tromethamine (KTR), was conducted. Sixteen healthy Korean male subjects were received each formulation at the dose of 30 mg as KTR in a 2×2 crossover study. There was an one-week washout period between the doses. Plasma concentrations of KTR were monitored by a HPLC method. AUC was calculated by the linear trapezoidal method. Cmax and Tmax were compiled from the plasma drug concentration-time data. Analysis of variance (ANOVA) revealed that there are no differences in AUC, Cmax and Tmax between the formulations. The differences between the formulations in these parameters were all far less than 20% (i.e., 3.65, 2.59 and 4.35% for AUC, Cmax and Tmax respectively). Minimum detectable differences (%) at α=0.1 and 1?β=0.8 were 12.87, 13.44, 20.62%, for AUC, Cmax and Tmax, respectively. The 90% confidence intervals for these parameters were also within 20%. These results satisfy the bioequivalence criteria of the Korea Food and Drug Administration (KFDA) guidelines (No. 1998-86). Therefore, these results indicate that the two formulations of KTR are bioequivalent.
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KEYWORD
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Ketorolac tromethamine, Kerola®, Tarasyn®, Bioequivalence, Intramuscular injections
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