A Phase 1, Randomized, Two-Period Crossover Study to Evaluate the Relative Bioavailability of Intravenous GTX-104 Compared to Oral Nimodipine Capsules at Steady State in Healthy Male and Female Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- AUC (AUCDay 3, 0-24hr)
研究概览
简要总结
This is a Phase 1, single center, randomized, two-period crossover study in healthy male and female subjects designed to evaluate the relative bioavailability (BA) and safety at steady state of two formulations of nimodipine: GTX 104 (nimodipine for intravenous [IV] infusion; test formulation) and nimodipine oral capsules, RS (reference formulation).
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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject had a body mass index between 18 and 32 kg/m2, inclusive.
- •Subject was in good general physical health as determined by absence of clinically significant (CS) medical or psychiatric history, physical examination findings, vital signs, clinical laboratory evaluations, and 12-lead ECG measurements.
排除标准
- •History or presence of clinically significant medical illness, including, but not limited to, cardiovascular, pulmonary, hematologic, endocrine, immunologic, dermatologic, neurologic, psychiatric, renal, hepatic, chronic respiratory, or gastrointestinal disease, that could have interfered with the interpretation of the study.
- •Had current or recent (within 6 months) history of gastrointestinal disease or any surgical or medical condition (eg, Crohn's or liver disease) that could potentially alter the absorption, metabolism, or excretion of the study drug.
研究组 & 干预措施
Treatment A (GTX-104 IV, Test):
Nimodipine was administered by infusion over 72 hours.
干预措施: GTX-104 (Drug)
Treatment B (NIMOTOP, RLD):
Nimodipine capsules (RS) administered orally with 240 mL of water at a dose level of 60 mg (two 30 mg capsules) q4h for 72 hours.
干预措施: Nimodipine Capsules (Drug)
结局指标
主要结局
AUC (AUCDay 3, 0-24hr)
时间窗: Day 3 from 8:00 AM to 8:00 AM from 0 to 24 hr
Area under the concentration-time curve
Cmax Day 1
时间窗: Day 1 for the first dose (8:00 AM dose)
Maximum concentration
次要结局
- Cmax Day 3 across all 6 doses(Day 3)
- Absolute bioavailability (F) Day 3(Day 3)
- Total body clearance of the drug from plasma after IV infusion (CL) Day 3(Day 3 from 8:00 AM to 8:00 AM from 0 to 24 h)
- Apparent total body clearance of the drug from plasma after oral administration (CL/F) Day 3(Day 3 from 8:00 AM to 8:00 AM from 0 to 24 h)