Conditions: Arthritis, Juvenile Rheumatoid
Keywords: Sulfasalazine delayed release tablets azulfidine entabs Pharmacokinetics Juvenile Idiopathic Arthritis (JIA)
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 2
Healthy volunteers: no

Brief summary:
This study will characterize the steady state pharmacokinetics of sulfasalazine delayed release tablets in pediatric Juvenile Idiopathic Arthritis patients. Data from this study will fulfill the post approval commitment to the FDA.

Detailed description:

Arms:
arm 1: Sulfasalazine delayed release tablets 30-60 mg/kg/day (divided into BID doses) for 6 days

Interventions: intervention 1: Sulfasalazine
Intervention descriptions: intervention 1: Sulfasalazine delayed release tablets 30-60 mg/kg/day (divided into BID doses) for 7 days. Blood sampling for Pharmacokinetic assessment to be performed on Day 7

Protocol document: