Proellex Pharmacokinetics Bridging Study
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Proellex peak plasma concentration (Cmax)
研究概览
简要总结
Healthy female subjects received a single dose of four different types of Proellex, the original 25 mg dose and three new formulations
详细描述
Healthy female subjects received a single dose of four different types of Proellex, the original 25 mg dose and three new formulations (24 and 50 mg dose). Blood was collected pre-dose, at specified intervals and 24 hours post dose. Each dose was separated by at least one week interval from the previous dose.
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 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Medically normal subjects with no significant abnormal findings at the screening physical examination as evaluated by the clinical Investigator
- •Subject was willing to remain in the clinic for the screening visit; and for the treatment visits (day -1, day of treatment and day 1; approximately 36 hrs per treatment visit)
排除标准
- •Post-menopausal women,
- •Subject with documented endometriosis
- •Subject with known uterine fibroids or vaginal polyps
研究组 & 干预措施
Proellex Formulation 1
25 mg Proellex Gelucire and PEG (original formulation)
干预措施: 25 mg Proellex (Drug)
25 mg Proellex Formulation 2
25 mg Proellex coated with MCC
干预措施: 25 mg Proellex (Drug)
25 mg Proellex Formulation 3
25 mg Proellex blended with MCC
干预措施: 25 mg Proellex (Drug)
50 mg Proellex Formulation 3
50 mg Proellex blended with MCC
干预措施: 50 mg Proellex (Drug)
结局指标
主要结局
Proellex peak plasma concentration (Cmax)
时间窗: 24 hours
Proellex time to peak plasma concentration (tmax).
时间窗: 24 hours
次要结局
- Terminal elimination half-life (t1/2).(24 hours)
- Vital signs evaluated at screening, treatment days 0 and 1. Clinical laboratory values obtained at screening, treatment days 0 and 1. Adverse events assessed at treatment visits and followed until resolution.(24 hours)
- The area under the plasma concentration over time curve from zero to the last measurable Proellex plasma concentration (AUC0-24) was calculated.(24 hours)
- The area under the plasma concentration over time curve from zero to infinity (AUC 0-infinity).(24 hours)