Bioequivalence Study Between Temozolomide Oral Suspension (Ped-TMZ) and Temodal® Capsules
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 3
- 主要终点
- Primary pharmacokinetic parameter: Cmax
研究概览
简要总结
Primary objective:
• Evaluate bioequivalence between Temozolomide Oral Suspension and Temodal® capsules for oral administration.
Secondary objectives:
- Define the pharmacokinetic parameters of Temozolomide Oral Suspension.
- Assess the buccal safety of Temozolomide Oral Suspension.
详细描述
The study is an open label, randomized, crossover, 2-period study in 30 male/female patients with primary CNS malignancies. Patients will receive, under fasting conditions, 200 mg/m² of Temozolomide Oral Suspension (Ped-TMZ) or Temodal®, as single oral administration in 2 different study periods depending on the randomization, with no wash out period between administrations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with newly diagnosed glioblastoma multiforme treated with temozolomide (200mg/m2) as monotherapy and patients with recurrent or progressive malignant glioma treated with temozolomide as monotherapy (200mg/m2).
- •Male and female patients at least 18 of age.
- •Non-pregnant, non-breast feeding female.
- •Body mass index (weight/height²) in the range of 18.5 to 30 kg/m².
- •Having given a written informed consent
排除标准
- •Co-administration of sodium valproate
- •Patients with (naso)gastric tubes
- •Patients receiving 150 mg/m² and not eligible to the 200 mg/m² dose
研究组 & 干预措施
Ped-TMZ
Single oral administration on D1 or D2 according to randomization at the dose of 200 mg/m2. Ped-TMZ will be administered using the provided dosing oral syringes and followed by a glass of 240 ml of water (for mouth rinsing) in sitting position and under fasting condition.
干预措施: Ped-TMZ (Drug)
Temodal capsule
Single oral administration on D1 or D2 according to randomization at the dose of 200 mg/m2. The administration will take place around 8:00 a.m. followed with 240 mL of tap water, in sitting position and under fasting condition
干预措施: Ped-TMZ (Drug)
结局指标
主要结局
Primary pharmacokinetic parameter: Cmax
时间窗: Day 1 or Day 2
The Cmax pharmacokinetic parameter will be determined from temozolomide plasma concentrations
Primary pharmacokinetic parameter: AUC0-t
时间窗: Day 1 or Day 2
The AUC0-t pharmacokinetic parameter will be determined from temozolomide plasma concentrations
次要结局
- Secondary pharmacokinetic parameter: tmax(Day 1 and Day 2)
- Secondary pharmacokinetic parameter: λ(Day 1 and Day 2)
- Secondary pharmacokinetic parameter: t1/2(Day 1 and Day 2)
- Secondary pharmacokinetic parameter: AUC0-inf(Day 1 or Day 2)
- Secondary pharmacokinetic parameter: residual area(Day 1 and Day 2)