Fig 5. Individual and Geometric Mean of Cmax versus Administered Dose.
A. Individual and geometric mean of Cmax represented using log-scale. Overall Cmax appears to increase in a dose proportional manner. B. Individual and geometric mean of Dose Normalized Cmax (DNCmax) (linear scale). There is considerable overlap in the range of individual DNCmax values, with a trend of a slightly greater than proportional increase in Cmax over the 3 to 180 mg UV-4 dose range. The range and mean DNCmax values were similar across the 360 to 1000 mg dose range. Dose proportionality was assessed utilizing a power model, the slope was approximately 1.1 over either the 333-fold (3 to 1000 mg) or the 33-fold (30 to 1000 mg) UV-4 dose range. The 90% CI estimates of 333-fold (1.078, 1.133) and 33-fold (1.048, 1.157) were not fully contained within the pre-specified confidence bounds (0.94, 1.06). Overall Cmax appears to increase in a generally dose proportional manner, especially at the higher doses of 360 mg and above.