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Therefore, for a precise characterization of the range of active moiety exposures, PM and EM subjects were enrolled in a 1:2 ratio. The PK parameters were summarized descriptively by moiety, treatment, dose and genotype (EMs and PMs). Plots of median predose concentrations for each treatment and dose level were visually examined to assess the attainment http://en.wikipedia.org/wiki/Temsirolimus of steady state. Safety evaluations included clinical monitoring, subject-reported AEs including serious AEs, vital signs (heart rate and blood pressure), 12-lead ECGs and clinical laboratory tests. Thirty subjects were enrolled in this study: 20 EMs and 10 PMs of CYP2D6. The age range was 19 to 53 years and the mean age was 31.9 years. Of the subjects enrolled, the majority were men (n= 19/30) and White (n= 27/30). The mean weight was 77.4?kg; the mean height was 173.8?cm and the mean BMI was 25.5?kg?m?2. The median concentration http://www.selleckchem.com/products/pifithrin-alpha.html vs. time profiles of tolterodine and 5-HMT following repeated doses of tolterodine ER and of 5-HMT following repeated doses of fesoterodine are shown in Figure?1A�CC and the pharmacokinetic values are summarized in Table?1 by EMs and PMs. Following tolterodine ER administration, 5-HMT is not formed in PMs of CYP2D6, with the exception of quantifiable but very low ( http://www.selleckchem.com/screening/pfizer-licensed-library.html was affected only to a modest extent (1.5- to twofold higher Cmax and AUC in PMs). The plasma concentration vs. time data over 24?h post dose on day 5 (4-mg dose) and 36?h post dose on day 10 (8-mg dose) were not adequate for accurate characterization of the half-life of tolterodine, particularly in PMs. The apparent terminal half-life of 5-HMT following 4-mg and 8-mg doses of fesoterodine was well characterized, and the mean �� SD values were 10.4 �� 4.3 and 7.6 �� 2.4?h, respectively, in EMs and 10.4 �� 1.9 and 9.6 �� 2.0?h, respectively, in PMs. There was no apparent difference in 5-HMT half-life between doses or between the EMs and PMs. Based on comparison of mean AUC values in CYP2D6 EMs who form 5-HMT after administration of both drugs, the bioavailability of 5-HMT was about 39% and 27% higher from fesoterodine compared with tolterodine ER at the 4- and 8-mg doses respectively. The pharmacokinetics of both 5-HMT and tolterodine appear to be dose-proportional, with the following exception of apparent lack of proportionality. Because of the zero and near-zero exposures of 5-HMT in PMs given tolterodine ER, the geometric mean Cmax and AUC values did not appear to be dose-proportional when the data were pooled across genotypes, but were dose-proportional in EMs.