An Open Label Non-randomized Study To Characterize The Steady State Pharmacokinetics Of Sulfasalazine Delayed Release Tablets In Children With Juvenile Idiopathic Arthritis
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- Pfizer
- 入组人数
- 2
- 试验地点
- 2
- 主要终点
- Sulfasalazine Time for Cmax (Tmax) at Steady State
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with a diagnosis of oligoarticular, polyarticular, psoriatic or enthesitis-related JIA as determined by ILAR criteria. Patients who have been continuously treated with generic sulfasalazine delayed release formulation and have tolerated the product for at least 3 months prior to study enrolment and who are switched to Azulfidine-EN at least 8 days prior to Day 0 are eligible.
- •Patients must be at least 6 years of age and has not reached his/her 18th birthday prior to the Baseline Visit (Day 0).
- •Onset of JIA must have occurred prior to the patient's 16th birthday.
- •Patients must weigh at least 20 kg.
- •Patients must be on sulfasalazine 500 mg delayed release tablets and the total daily dose must be within the specified range of 30-60 mg/kg/day with a maximum daily dose of 3 g/day
排除标准
- •Patient currently with systemic features of systemic JIA.
- •Hypersensitivity to sulfasalazine , its metabolites, sulfonamides or salicylates.
- •History of sensitivity to heparin or heparin-induced thrombocytopenia.
- •Inability to swallow whole (uncrushed) sulfasalazine 500 mg delayed release tablets as required by protocol
研究组 & 干预措施
1
Sulfasalazine delayed release tablets 30-60 mg/kg/day (divided into BID doses) for 6 days
干预措施: Sulfasalazine (Drug)
结局指标
主要结局
Sulfasalazine Time for Cmax (Tmax) at Steady State
时间窗: 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
时间窗: Day 7 predose, and 2, 4, 6, 10, and 12 hours postdose
Sulfapyridine Tmax at Steady State
时间窗: Day 7 predose, and 2, 4, 6, 10, and 12 hours postdose
Sulfapyridine and 5-ASA are primary metabolites of sulfasalazine, the study drug.
5-aminosalicylic Acid (5-ASA) Tmax at Steady State
时间窗: Day 7 predose, and 2, 4, 6, 10, and 12 hours postdose
Sulfapyridine and 5-ASA are primary metabolites of sulfasalazine, the study drug.
Sulfasalazine Steady State Maximum Plasma Concentration (Cmax) and Predose Concentration (Cmin)
时间窗: Day 7 predose, and 2, 4, 6, 10, and 12 hours postdose
Sulfapyridine AUCtau at Steady State
时间窗: Day 7 predose, and 2, 4, 6, 10, and 12 hours postdose
Sulfapyridine and 5-ASA are primary metabolites of sulfasalazine, the study drug.
5-aminosalicylic Acid (5-ASA) Steady State Cmax and Cmin
时间窗: Day 7 predose, and 2, 4, 6, 10, and 12 hours postdose
Sulfapyridine and 5-ASA are primary metabolites of sulfasalazine, the study drug.
Sulfapyridine Steady State Cmax and Cmin
时间窗: Day 7 predose, and 2, 4, 6, 10, and 12 hours postdose
Sulfapyridine and 5-aminosalicylic acid (5-ASA) are primary metabolites of sulfasalazine, the study drug.
5-aminosalicylic Acid (5-ASA) AUCtau at Steady State
时间窗: Day 7 predose, and 2, 4, 6, 10, and 12 hours postdose
Sulfapyridine and 5-ASA are primary metabolites of sulfasalazine, the study drug.
次要结局
- Number of Participants With Vital Signs Values Meeting Categorical Summarization Criteria(Screening, Day 0, and Day 7)
- Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Withdrawals Due to TEAEs(Screening through to and including 28 calendar days after the last administration of the investigational product)
- Number of Participants With Laboratory Test Abnormalities(Screening, Day 0, and Day 7)