Full text loading...
薬理と治療
Abstract
Aripiprazole 0.1% oral solution is a new formulation that was developed for easier swallowingby schizophrenia patients with dysphagia and for use in patients in whom treatmentusing a tablet formulation is difficult and compliance is unreliable, such as those who tend torefuse drug therapy because they cannot understand the necessity of taking the drug due totheir clinical state.The bioequivalence of 3 mL of aripiprazole 0.1% oral solution and one aripiprazole 3 mgtablet was evaluated by comparing the pharmacokinetics of the two formulations following singleoral administration in 22 healthy adult male subjects under a fasting condition in a 2−treatment,2−period, open−label crossover trial. A washout period of 35 days was set betweenstudy drug administration in PeriodsI and II.The 90% CI(confidence intervals)for the differences in the mean log−transformedAUC168h and Cmax values between 3 mL of aripiprazole 0.1% oral solution and one aripiprazole3 mg tablet were respectively log(0.99)to log(1.07)and log(0.97)to log(1.08). As bothwere within the bioequivalence criteria range of log(0.8)to log(1.25), it was judged that thetwo formulations were bioequivalent.All of the adverse drug reactions in this study have been reported as adverse drug reactionsfor aripiprazole in previous oral aripiprazole studies performed prior to this study inJapan. Aripiprazole 0.1% oral solution is therefore considered to pose no particular safetyproblems.No death or serious adverse events or clinically significant adverse events occurred.(Jpn Pharmacol Ther 2008;36:1131−9)KEY WORDS Aripiprazole, Atypical antipsychotics, Healthy adult male subjects, Oral solution,Bioequivalence
Data & Media loading...