Asenapine pharmacokinetics and tolerability in a pediatric population.

ABSTRACT:

Purpose

This study aimed to characterize the pharmacokinetic (PK) properties, safety, and tolerability of asenapine, and to develop a population PK model in pediatric patients with schizophrenia, bipolar disorder, or other psychiatric disorders.

Methods

Two Phase I multiple ascending-dose studies were conducted to evaluate the PK, safety, and tolerability of sublingual asenapine in pediatric patients (age 10-17 years) with schizophrenia or bipolar I disorder. Patients received asenapine 1-10 mg twice daily for up to 12 days. PK parameters (maximum concentration [C_max], area under the curve from 0 to 12 hours [AUC_0-12], time to C_max [T_max], and half-life) were summarized for asenapine with descriptive statistics, and safety paramete

SUBMITTER: Dogterom P 

PROVIDER: S-EPMC6124477 | biostudies-literature | 2018

REPOSITORIES: biostudies-literature