Pharmacokinetics of a Medium Chain Triglyceride Oil Oxandrolone Solution vs. Tablets in Healthy Adults: A Relative Bioavailability Study
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Peak Plasma Concentration (Cmax) curve
研究概览
简要总结
To assess the pharmacokinetics and relative bioavailability of a single dose of approximately 0.1 mg/kg of a medium chain triglyceride (MCT) oil oxandrolone solution vs. tablets in a small cohort of healthy adults.
详细描述
The results of this study will provide data regarding the relative bioavailability of a novel preparation of oxandrolone in MCT oil, which will allow dosing in neonates and small infants. This pilot study will provide information to design a larger multicenter study of neonates undergoing surgery for complex congenital heart disease.
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
- 18 Years 至 35 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Age 18 to 35 years (inclusive) at the time of screening
- •Body mass index [BMI, body weight (kg)/height (m)2] below 30 kg/m2
- •Medically healthy
排除标准
- •Known allergy to anabolic steroids
- •Use of any prescription medication currently or within 14 days prior to dosing
- •Use of tobacco or nicotine containing products (including smoking cessation products), within 6 months prior to dosing
- •Any chronic medical condition
- •Seated blood pressure <90/40 mmHg or >140/90 mmHg at screening
- •Heart rate <40 or >99 at screening
- •Subjects who have taken any investigational drug within 30 days prior to first dose in the current study
研究组 & 干预措施
Oxandrin
Administration of a single dose of approximately 0.1 mg/kg of a medium chain triglyceride (MCT) oil Oxandrin (oxandrolone) solution vs. 01.mg/kg tablets in a small cohort of healthy adults. Participants will be dosed at two time points one week apart.
干预措施: Oxandrin (Drug)
结局指标
主要结局
Peak Plasma Concentration (Cmax) curve
时间窗: Measurement of Peak Plasma Concentration (Cmax) at 15 min, 30 min, 1, 2, 3, 4, 8, 24, 48 hours on Days 1 and 8
The primary outcome for this study will be the pharmacokinetics of a single dose of oxandrolone 0.1 mg/kg both in tablet form and in the MCT oil preparation as measured by peak plasma concentration (Cmax) curve
Area under the plasma concentration versus time curve (AUC)
时间窗: Measurements at 15 min, 30 min, 1, 2, 3, 4, 8, 24, 48 hours on Days 1 and 8
The primary outcome for this study will be the pharmacokinetics of a single dose of oxandrolone 0.1 mg/kg both in tablet form and in the MCT oil preparation as measured by the area under the plasma concentration versus time curve (AUC).
次要结局
- Safety will be assessed by recording adverse events and assessment of hepatic function at baseline and one week following oxandrolone dosing.(Liver function will be assessed by measuring serum transaminase levels at baseline and 1 week after each oxandrolone dose in the study participants, and any adverse events throughout the study period and up to 1 week after final dosing will be recorded.)