NRP290:
Second
Phase I study
n
Comparing
hydrocodone from NRP290 (1x12mg) to Vicodin
®
(1x5/500mg)
•
The
90% confidence
intervals for peak and overall exposure parameters of
hydrocodone based on
ln(C
max
), ln(AUC
last
) and ln(AUC
inf
) were
within
80% to 125%. Therefore, a single dose of NRP290 12 mg is bioequivalent
to
the single dose of Vicodin
®
5/500 mg under fasting
conditions.
n
Comparing
hydrocodone from NRP290 (1x24mg) to Vicodin
®
(2x5/500mg)
•
The
90% confidence
intervals for peak of hydrocodone based on ln(C
max
)
was within 80%
to 125%. The upper limit of 90% confidence intervals for overall
exposure
parameters of hydrocodone based on ln(AUC
last
) and
ln(AUC
inf
)
were slightly higher(128.51% and 134.67%).
n
Intact
NRP290 conjugates
•
No
intact NRP290
conjugates observed in systemic circulation in either dose.