The accuracy (per cent bias) values calculated from the QC sample

The accuracy (per cent bias) values calculated from the QC samples ranged from 2.0 to 4.2% and the overall precision (per cent coefficient of variation) was≤8.6%. Twenty-four-hour pharmacokinetic assessments were performed on day 7 of period 1 and on day 14 of periods 2 and 3. Only subjects with >95% adherence per medication pillbox Galunisertib in vivo and diary monitoring by research staff were allowed to continue with pharmacokinetic sampling. Standard pharmacokinetic parameters [AUC, elimination half-life (t1/2), maximum plasma concentration (Cmax), time of Cmax (Tmax) and minimum plasma concentration (Cmin)] were determined using noncompartmental methods

(WinNonlin v4.0.1; Pharsight, Mountain View, CA, USA), and were log-transformed (with the exception

of Tmax) before statistical analysis. Selleckchem Anti-diabetic Compound Library For each study drug pharmacokinetic parameter, geometric mean ratios (GMRs) with 90% confidence intervals (CIs) were assessed and compared among regimens. The sample size needed for this study was determined by reviewing data from four previous APV pharmacokinetic studies in healthy adult subjects receiving FPV/RTV (APV10009, APV10011, APV10013 and APV10022) [21] and the statistical analyses that had been applied to each of these. Assuming an intra-subject standard deviation of 0.29, the maximum variability observed across studies conducted, 12 evaluable subjects were deemed necessary for the FPV vs. TDF comparison and 12 for the FPV/RTV vs. TDF comparison. All subjects who received study medication were considered evaluable for safety analysis. The investigators used their clinical Bcl-w judgment to ascertain any possible relationship of reported adverse events to the study drugs. Thirty-nine healthy volunteers were enrolled, of whom 31 completed all three treatment arms. Eight subjects

discontinued the study for one or more of the following reasons: pregnancy (one subject), loss to follow-up (two subjects), grade 2 nausea/vomiting (one subject), grade 2–4 maculopapular rashes (six subjects). As no treatment, period or gender effects were observed in groups A and B or in groups C and D (data not presented), these respective groups were combined for analysis. The mean age of the 31 evaluable subjects was 31.5 years (range 19–67 years) and mean weight was 78.6 kg (range 51–120 kg). The study population was diverse with respect to gender [48% (15 of 31) male and 52% (16 of 31) female] and race/ethnicity [71% (22 of 31) Caucasian, 23% (seven of 31) African American, and 6% (two of 31) other]. Steady-state plasma concentrations of APV and TFV over the interval following dosing with each regimen are shown in Figure 1. During the unboosted FPV dosing period, the steady-state geometric mean APV Cmin, Cmax and AUC were 0.266 μg/mL, 4.759 μg/mL and 17.342 μg·h/mL, respectively. During unboosted FPV/TDF coadministration, these values increased by 31, 3 and 7%, respectively (Table 1).

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