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KMID : 0366919970090010067
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Sungkyun Pharmceutical Journal
1997 Volume.9 No. 1 p.67 ~ p.71
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Bioequivalence of Nicotine Patches
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Abstract
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The bioequivalence of two nicotine patches was evaluated in 16 normal male volunteers (age 21∼27 yrs) following single transdermal application. Test product was "Nicostop patch" made by Sam Yang Co. and reference product was "Nicotinell TTS patch" made by Korean Searle Ciba-Geigy Co. After nicotine patches were applied onto the inside of the forearm, blood was taken at predetermined time intervals and the nicotine concentration in plasma was determined with a sensitive GC method using NPD detector. AUC and C_max the differences in AUC and C_max between two products were 5.47% and 2.70%, respectively. The powers (1-β) for AUC and C_max were ＞90% and 88.76%, respectively. Detectable differences(△) and confidence intervals were all less than 20%. All of these parameters met the criteria of KFDA for bioequivalence, indicating that "Nicostop patch" is bioequivalent to "Nicotinell TTS patch".
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KEYWORD
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