Aripiprazole orally disintegrating tablet is a new formulation that was
developed for easier swallowing by schizophrenia patients with dysphagia and
for use in patients in whom treatment using a conventional tablet or powder
formulation is difficult or adherence is unreliable, such as patients who tend
to refuse drug therapy because they cannot understand the necessity of taking
the drug due to their clinical state.
The two trials were conducted using a randomized, two-treatment, two-period,
open-label crossover method to verify the bioequivalence of 3-mg of aripiprazole
orally disintegrating tablets to 3-mg of aripiprazole conventional tablets,
under fasting conditions, in 44 healthy adult male subjects. One trial
was the without-water trial which the orally disintegrating tablets was
administered without water in. Another trial was the with-water trial
which the orally
disintegrating
tablets was administered with water in. A washout period of 35 days was
set between study drug administration in Periods I and II.
In the without-water trial, the 90％ CI（confidence intervals）for the
differences in the mean log-transformed AUC168h and Cmax values between the
orally disintegrating tablet without water and the conventional tablet were
log（0.96）to log（1.04）and log（0.97）to log（1.07）respectively. In the with-water
trial, the 90％ CI for the differences in the mean log-transformed AUC168h and
Cmax values between the orally disintegrating tablet with water and the conventional
tablet were log（0.92）to log（1.04）and log（0.88）to log（1.02）respectively. As
both 90％ CI in both trials were within the bioequivalence criteria range of
log（0.8）to log（1.25）, it was judged that the two formulations were bioequivalent.
All of the adverse drug reactions observed in this study have been
previously reported as adverse drug reactions for aripiprazole in prior oral
aripiprazole studies conducted in Japan, and aripiprazole orally disintegrating
tablet is therefore considered to pose no particular safety problems. No deaths
or serious adverse events occurred.