Comparative Bioavailability Pilot Study of 3 W0035 Test Oral Suspensions (Ivermectin 1mg/mL) Versus Stromectol® (Ivermectin, 3 mg Tablet) After Single Oral Administration in Healthy Volunteers. Single Centre, Open Label, Crossover, Randomized, 5-period, 20-sequence, Partial Replicate, Single Dose Design
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Concentration of ivermectin
研究概览
简要总结
Ivermectin is prescribed for the treatment of helminthic infections sensitive to ivermectin. However, it is currently only available as a tablet formulation. W0035 is a powder for oral suspension of ivermectin developed by PIERRE FABRE DERMATOLOGIE intended to be administered to children for the treatment of helminthic infections sensitive to ivermectin and mentioned in the Summary of Product Characteristics (SmPC) of Stromectol.
PIERRE FABRE DERMATOLOGIE intends to carry out this pilot bioavailability study in order to define the most appropriate formulation to be used in the bioequivalence study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •18.5 ≤ BMI ≤ 30.0 kg/m².
- •Non-smoker subject with a breath carbon monoxide reading of ≤10 ppm at screening.
- •Agree to use effective contraception method
排除标准
- •most specific out of
- •History of or current symptomatic orthostatic hypotension
- •Hyper-eosinophilia or subject at risk of microfilaremic disease or clinical suspicion of intestinal helminth infection
- •History of or current macroscopic or microscopic hematuria
- •Positive serology for Hepatitis Bs antigen (HBs), Hepatitis C Virus (HCV) and HIV 1 and 2 antibodies.
- •Organic disorder likely to modify, absorption, distribution or elimination of the medication.
研究组 & 干预措施
ivermectin T2
T2= ivermectin medium grade particle Size Distribution
干预措施: ivermectin T3 (Drug)
ivermectin T3
T= ivermectin high grade particle Size Distribution
干预措施: ivermectin T3 (Drug)
ivermectin T3
T= ivermectin high grade particle Size Distribution
干预措施: ivermectin T2 (Drug)
ivermectin T3
T= ivermectin high grade particle Size Distribution
干预措施: ivermectin T1 (Drug)
ivermectin T2
T2= ivermectin medium grade particle Size Distribution
干预措施: ivermectin T2 (Drug)
ivermectin T2
T2= ivermectin medium grade particle Size Distribution
干预措施: ivermectin T1 (Drug)
ivermectin T1
T1= ivermectin low grade particle Size Distribution
干预措施: ivermectin T3 (Drug)
ivermectin T1
T1= ivermectin low grade particle Size Distribution
干预措施: ivermectin T2 (Drug)
ivermectin T1
T1= ivermectin low grade particle Size Distribution
干预措施: ivermectin T1 (Drug)
Stromectol R
Stromectol R = ivermectin 3mg (tablet)
干预措施: ivermectin T3 (Drug)
Stromectol R
Stromectol R = ivermectin 3mg (tablet)
干预措施: ivermectin T2 (Drug)
Stromectol R
Stromectol R = ivermectin 3mg (tablet)
干预措施: ivermectin T1 (Drug)
结局指标
主要结局
Concentration of ivermectin
时间窗: 5 periods of 3 days each
At each period: 17 blood samples: T0 (Pre-dose), T0 +15min, T0 +30min, T0 +1h, T0+1h30min, T0 +2h, T0 +2h30, T0 +3h, T0 +3h30, T0 +4h, T0 +4h30, T0 +5h, T0 +6h, T0 +12h, T0 +24h, T0 +48h and T0 +72h
次要结局
未报告次要终点