CompletedNCT01206517
Asenapine Drug Levels and Safety in Children With Schizophrenia or Bipolarity
About this title
A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Sublingual Asenapine in a Pediatric Population With Schizophrenia or Bipolar I Disorder (P06522 AM1)
Read the official source — NCT01206517Medication studyAges 10–17
Understand this study
Who was this study for?
Listed age limits: 10 years to 17 years.
- Study phase
- Phase 1Usually an early study focused on safety, tolerability, dosage, and side effects.
Study information
Study start dateStarted: July 18, 2010
- Recruitment status
- Completed
- Enrollment listed in the registry
- 30
- Sponsor
- Organon and Co
- Sponsor type
- Unknown or unclear
- Study type
- Drug
- Intervention type
- Medication / drug
- Study phase
- Phase 1Usually an early study focused on safety, tolerability, dosage, and side effects.
- Locations
- Not clearly listed
- Age range
- From 10 Years to 17 Years
- Official registry ID
- NCT01206517
- Official title
Show the full official title
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
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Recruitment & locations
CompletedLocations not listed
Questions about this study
Who is behind this study?
The study sponsor is Organon and Co.
Did this study involve medication?
Yes. The study involved medication, including Asenapine 2.5 mg, Asenapine 5 mg and Asenapine 10 mg.
Who was this study for?
Listed age limits: 10 years to 17 years.
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