Fesoterodine subjects and is consistent with adequate duration of wash-out intervals

Fesoterodine confidence intervals for and Table lists the same values for AZE. Study : FP concentrations could be quantified throughout the 4 hour post-dose sampling with one exception for one subject . Pre-dose serum concentrations were below LLOQ in all periods in all subjec which is consistent with an adequate of wash-out interval between study treatments. All treatments resulted in rapid absorption of FP from the nasal mucosa with median t max values within hour after dosing. Serum FP profiles were similar after M and M-FP-mono. Respective geometric mean C max values were was and pg/ and corresponding mean AUC-t values were and pg h/ml.

Peak and total FP systemic exposure from marketed FP-BI was somewhat lower with  ARRY-520 geometric means for C max of pg/ml and AUC-t of pg h/ml. Despite this numerical differen maximum FP exposure was generally l indicating an overall very limited 2 The Authors British Journal of Clinical Pharmacology The British Pharmacological Society Accepted Article systemic FP bioavailability for all investigational treatments. Mean FP serum concentration-time profiles displayed a rapid initial increase that peaked around 5 minutes post-do with a discrete transient second peak at about h 5 min post-dose consistently noted with all products. The concentration-time profile of the marketedparator treatment could be distinguished from the M-based treatmen with consistently lower concentrations at all time points over the first hours post-dose.

From 2 hours post-dose onwar howev no meaningful differences between any of the  Cilostazol 73963-72-1 treatments were notable. Average concentration-time curves displayed an apparent tri-exponential decline of FP serum levels with a sustained decline of very low residual concentrations from 2 hours post-dose onwards. This long terminal disposition phase of FP has not been captured and described in previous studies using less sensitive assa and represents therefore an unexpected finding. Consequent the extrapolated fraction of the AUC values exceeded in many subjects the cut-off value of 0 of the total AUC. Therefo AUC-t was selected to estimate total drug exposure. Table shows C max and AUC-t ratios of M /M-FP-mono and indicate equivalent exposure. The corresponding ratios of M /FP-BI point to a difference of about 0 for maximum and total average FP exposure. Study : The mean concentration-time profiles of all treatments were buy nisoldipine essentially identical and are nearly superimposable as shown in Figure .

As with AZE pre-dose plasma concentrations were below LLOQ for all periods in all subjects and is consistent with adequate duration of wash-out intervals. The rate of absorption was very rapid with initial peak-concentrations at 5 min post-dose followed by a transient decline. Median t max values were consistently noted for all treatments at or in less than hours. Somewhat lower secondary concentration peaks were seen at h post-dose followed by a further transient decline in AZE plasma concentrations. Final third 3 The Authors British Journal of Clinical Pharmacology The British Pharmacological  bacteria Society Accepted Article peaks were observed at h post-dose. The results of the ANOVA analysis actually confirm equivalent systemic maximum and total AZE exposure in terms of C max and AUC-t for theparison of M with both.

Leave a Reply

Your email address will not be published. Required fields are marked *

*

You may use these HTML tags and attributes: <a href="" title=""> <abbr title=""> <acronym title=""> <b> <blockquote cite=""> <cite> <code> <del datetime=""> <em> <i> <q cite=""> <strike> <strong>