A Study to Evaluate the Safety and Tolerability of Sublingual Asenapine in a Pediatric Population With Schizophrenia or Bipolar I Disorder (Study P06522)
| Status: | Archived |
|---|---|
| Conditions: | Schizophrenia, Psychiatric, Bipolar Disorder |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 7/1/2011 |
| Start Date: | July 2010 |
| End Date: | May 2011 |
A Sequential Groups, Open Label, Rising Multiple Dose Study to Assess the Pharmacokinetics, Safety and Tolerability of Sublingual Asenapine in a Pediatric Population With Schizophrenia or Bipolar I Disorder
This study is an open label, sequential-group, two site, multiple dose escalating study of
sublingual administered asenapine in a pediatric population with schizophrenia or bipolar I
disorder. Patients will receive a single sublingual placebo dose on Day -1, followed by
multiple sublingual doses of asenapine twice daily (b.i.d.) for 6 (cohorts 1 and 2) or 7
days (cohort 3), and a final once daily (q.d.) administration on Day 7 (cohorts 1 and 2) or
Day 8 (cohort 3).
We found this trial at
2
sites
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