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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
2
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
University Hospitals Case Medical Center
Cleveland, Ohio, United States
Private Office
Guadalajara, Jalisco, Mexico
Sulfasalazine Steady State Maximum Plasma Concentration (Cmax) and Predose Concentration (Cmin)
Time frame: Day 7 predose, and 2, 4, 6, 10, and 12 hours postdose
Sulfasalazine Time for Cmax (Tmax) at Steady State
Time frame: Day 7 predose, and 2, 4, 6, 10, and 12 hours postdose
Sulfasalazine Area Under the Concentration-time Profile From Time 0 to Time Tau, the Dosing Interval (AUCtau) at Steady State
Time frame: Day 7 predose, and 2, 4, 6, 10, and 12 hours postdose
Sulfapyridine Steady State Cmax and Cmin
Sulfapyridine and 5-aminosalicylic acid (5-ASA) are primary metabolites of sulfasalazine, the study drug.
Time frame: Day 7 predose, and 2, 4, 6, 10, and 12 hours postdose
Sulfapyridine Tmax at Steady State
Sulfapyridine and 5-ASA are primary metabolites of sulfasalazine, the study drug.
Time frame: Day 7 predose, and 2, 4, 6, 10, and 12 hours postdose
Sulfapyridine AUCtau at Steady State
Sulfapyridine and 5-ASA are primary metabolites of sulfasalazine, the study drug.
Time frame: Day 7 predose, and 2, 4, 6, 10, and 12 hours postdose
5-aminosalicylic Acid (5-ASA) Steady State Cmax and Cmin
Sulfapyridine and 5-ASA are primary metabolites of sulfasalazine, the study drug.
Time frame: Day 7 predose, and 2, 4, 6, 10, and 12 hours postdose
5-aminosalicylic Acid (5-ASA) Tmax at Steady State
Sulfapyridine and 5-ASA are primary metabolites of sulfasalazine, the study drug.
Time frame: Day 7 predose, and 2, 4, 6, 10, and 12 hours postdose
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5-aminosalicylic Acid (5-ASA) AUCtau at Steady State
Sulfapyridine and 5-ASA are primary metabolites of sulfasalazine, the study drug.
Time frame: Day 7 predose, and 2, 4, 6, 10, and 12 hours postdose
Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Withdrawals Due to TEAEs
An adverse event (AE) was any untoward medical occurrence attributed to study drug in a participant who received study drug. TEAEs are defined as newly occurring AEs or those worsening after first dose. AEs comprised both SAEs and non-SAEs. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Time frame: Screening through to and including 28 calendar days after the last administration of the investigational product
Number of Participants With Laboratory Test Abnormalities
Number of participants with laboratory test abnormalities without regard to baseline abnormality. Laboratory test parameters included hematology, coagulation, liver function, renal function, electrolytes,clinical chemistry, and urinalysis (dipstick and microscopy).
Time frame: Screening, Day 0, and Day 7
Number of Participants With Vital Signs Values Meeting Categorical Summarization Criteria
Vital sign values which met categorical summarization criteria included: supine/sitting pulse rate less than (\<) 40 or more than (\>) 120 beats per minute (bpm); erect pulse rate \<40 or \>140 bpm; changes from baseline in same posture of systolic blood pressure (SBP) more than or equal to (\>=) 30 millimeters of mercury (mm Hg) or diastolic blood pressure (DBP) \>=20 mm Hg; SBP \<90 mm Hg; and DBP \<50 mm Hg.
Time frame: Screening, Day 0, and Day 7