PMID- 7657849 OWN - NLM STAT- MEDLINE DCOM- 19950929 LR - 20190825 IS - 0091-2700 (Print) IS - 0091-2700 (Linking) VI - 35 IP - 5 DP - 1995 May TI - Comparison of the pharmacokinetics of two nicotine transdermal systems: nicoderm and habitrol. PG - 493-8 AB - This randomized, crossover study compared the nicotine and cotinine pharmacokinetic parameters and plasma concentration profiles of two different nicotine transdermal products: Nicoderm (Alza, Palo Alto, CA; and Marion Merrell Dow, Kansas City, MO) and Habitrol (Basel Pharmaceuticals, Summit, NJ). The two treatments were randomly assigned to each of 24 male smokers and worn for 24 hours each day for 5 days, with a 6-day washout between treatments. Plasma nicotine and cotinine concentrations were measured on day 1 and day 5 of each treatment. Mean delivered dose differed significantly between products, and the two products were not bioequivalent. The Nicoderm system provided higher mean plasma nicotine concentrations, particularly during the first 8 hours after system application. The mean steady state Cmax, AUC, and degree of fluctuation (DF) values were significantly greater for the Nicoderm system than for Habitrol. The mean nicotine tmax value for the Nicoderm system was significantly shorter (P < .001) than that for Habitrol (2.7 versus 8.6 hours). Steady state cotinine AUC values and plasma concentrations were significantly lower for Habitrol than for the Nicoderm system. The incidence of adverse events was similar for both products. FAU - Gupta, S K AU - Gupta SK AD - Alza Corporation, Palo Alto, California 94304, USA. FAU - Okerholm, R A AU - Okerholm RA FAU - Eller, M AU - Eller M FAU - Wei, G AU - Wei G FAU - Rolf, C N AU - Rolf CN FAU - Gorsline, J AU - Gorsline J LA - eng PT - Clinical Trial PT - Comparative Study PT - Journal Article PT - Randomized Controlled Trial PL - England TA - J Clin Pharmacol JT - Journal of clinical pharmacology JID - 0366372 RN - 6M3C89ZY6R (Nicotine) RN - K5161X06LL (Cotinine) SB - IM MH - Administration, Cutaneous MH - Adult MH - Analysis of Variance MH - Cotinine/blood/*pharmacokinetics MH - Cross-Over Studies MH - Humans MH - Male MH - Middle Aged MH - Nicotine/blood/*pharmacokinetics EDAT- 1995/05/01 00:00 MHDA- 1995/05/01 00:01 CRDT- 1995/05/01 00:00 PHST- 1995/05/01 00:00 [pubmed] PHST- 1995/05/01 00:01 [medline] PHST- 1995/05/01 00:00 [entrez] AID - 10.1002/j.1552-4604.1995.tb04093.x [doi] PST - ppublish SO - J Clin Pharmacol. 1995 May;35(5):493-8. doi: 10.1002/j.1552-4604.1995.tb04093.x.