However, Cmax and mean insulin concentration following the Phoslyra treatment, while not significantly different, were 17% and 11% lower, respectively, compared to PhosLo Gelcaps.
Diarrhea was found to be more common in the Phoslyra group.
The present study evaluated the bioequivalence between Phoslyra and PhosLo Gelcaps.
13) Observation of these changes in the present study population provided confidence that a finding of "no difference" between Phoslyra and PhosLo Gelcap formulations could not be attributed to methodological flaws in trial design and/ or conduct.
Based on the serum phosphorus Cmax (peak concentration) and the AUCO-6 (area under the curve from time 0 - 6hrs), the analysis of the primary endpoints demonstrated bioequivalence between Phoslyra and PhosLo Gelcaps.
Of the secondary endpoints, strict bioequivalence was demonstrated for serum Ca between Phoslyra and PhosLo Gelcaps.
Upon review of AEs (Table 7), vital signs, and safety laboratory parameters, Phoslyra was found to be well-tolerated with no safety issues.
The analysis of the 6-hour glucose and insulin levels in serum did not indicate any significant influence of maltitol on serum glucose control in the Phoslyra cohort.