The t½ was calculated as 0.693/λz . The total clearance after oral administration (CL/F) was calculated as dose/AUC∞. Descriptive statistics, including mean values and standard deviations (SDs), were used to summarize the pharmacokinetic data for the two drugs. Statistical analyses were performed using SAS version
9.0.2 software (SAS Institute Inc., Cary, NC, USA). An analysis of variance (ANOVA) was performed on the natural logarithm (ln)-transformed pharmacokinetic parameters (the AUCt, AUC∞, and Cmax), using the general linear models procedures in SAS. The ANOVA model had fixed factors for sequence, treatment, period, and subject within GW572016 sequence. The PF-3084014 clinical trial Wilcoxon signed-rank test was used for nonparametric analysis to determine differences in the tmax. If the 90% confidence intervals (CIs) of the AUC and Cmax were located within 80–125% of the statistical interval proposed by the FDA , the two drugs would be considered bioequivalent. On the basis of the variability reported in a previous trial in India and the Chinese SFDA guidance , the number of subjects required to demonstrate bioequivalence at a significance level of 5% with 90% power was calculated
Vorinostat mw to be 24. 3 Results 3.1 Demographic Data A total of 24 healthy male Chinese volunteers were enrolled, and all completed the study. The demographic characteristics of the study population are summarized in Phloretin Table 1. Table 1 Baseline demographic and clinical characteristics of the study population (n = 24 healthy Chinese male volunteers) Characteristic Value Age
(years) Mean [SD] 22.9 [2.7] Range 19.2–27.1 Weight (kg) Mean [SD] 63.2 [7.0] Range 52.0–78.0 Height (cm) Mean [SD] 171.3 [6.1] Range 162.0–187.0 Body mass index (kg/m2) Mean [SD] 21.5 [1.3] Range 19.3–23.7 SD standard deviation 3.2 Tolerability The tolerability of the two formulations of risperidone, each given in a single administration, was acceptable. No serious AEs occurred during treatment with the test formulation or the reference formulation. A total of 73 AEs were observed in 24 subjects during the study, and the event rate was similar with both formulations (37 AEs occurred after intake of the test formulation, while 36 AEs occurred after intake of the reference formulation). The most common AE was sedation (48 events), followed by nasal reactions (14 events), postural hypotension (3 events), hypertriglyceridemia (2 events), dizziness (4 events), nausea (1 events), and anorexia (1 events). Their severity was as follows: 16 were mild, 57 were moderate, and none were severe. The majority of the AEs were considered to be related (48 events) or probably related (23 events) to the study medication. No clinically significant abnormalities on physical examination, vital sign measurements, or electrocardiographic recordings were reported. 3.