Conditions: Opioid Analgesia
Keywords: Pediatric Post-operative Nonsurgical patients Opioid
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 30
Healthy volunteers: no

Brief summary:
The purpose of this study is to characterize the pharmacokinetics (PK) of single-dose ORF tablets in pediatric patients aged 6 to 16 years, inclusive.

Detailed description:

Arms:
arm 1: ORF Tablets

Interventions: intervention 1: Oxycodone hydrochloride controlled-release (ORF) tablets
Intervention descriptions: intervention 1: Oxycodone hydrochloride controlled-release (ORF) tablets (10 mg, 15 mg or 20 mg) taken every 12 hours

Protocol document: