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KMID : 0370119950290020063
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Journal of Pharmacetical Scences Pusan University
1995 Volume.29 No. 2 p.63 ~ p.72
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Bioequivalence Test of Fortec (Dimethyl Dicarboxyl Biphenylate) Tablets
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Abstract
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Bioequivalence test of two dimethyl dicarboxyl biphenylate(DDB) bablets was performed in 12 normal male volunteers(age 20-24 yr, body weight 54-72 kg) following single oral administration. Test and reference tablet were Fortec(Dong-Kwang Corp.
Seoul)and
Nissel (Tae-Rim Corp. Seoul), respectively. the volunteers were randomly divided into 2 groups and reference (Nissel) and test(Fortec) tablets (25 mg of DDB/tablet) were administered orally by randomized two period cross-over study (2×Latin
square
method). Average plasma concentration at each sampling time and pharmacokinetic parameters calculated were not significantly different between two tablets(p>0.05). The differences of mean AUC 0-8 hr (area under the concentration-time curve to
last
sampling time, 8 hr), Cmax maximum plasma concentration), and Tmax (time to maximum ploasma concentration) between test and reference tablets were less than 20%. These results suggested that the bioavailability of Fortec tablet was not different
from
that of Nissel and they were bioequivalent with each other in AUC, Cmax and Tmax.
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