NCT01327352已完成不适用
A Single Center, Non-randomized, Placebo Controlled Study for the Evaluation of the Influence of Food Regimen on Oshadi D Absorption
Oshadi Drug Administration1 个研究点 分布在 1 个国家目标入组 8 人开始时间: 2011年4月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- DNase activity level (Kunitz/mL) for 2 dose levels, and different food regimen
研究概览
简要总结
The study will be a non-randomized, open label, single dose, placebo control, single center, and single arm study in healthy subjects. The study will include one administration of placebo and four single administrations of Oshadi D in two different dose levels, administered in two feeding regimen for the evaluation of the influence of food on Oshadi D absorption.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy Male/female 21 years old and up.
- •Subject must understand and be willing to give written informed consent prior to any study procedures or evaluations and be willing to adhere to all study schedules and requirements.
- •Subject must be sterile or infertile or use an approved method of contraception from the time that the first dose of study medication is taken until three months following study completion or discontinuation.
排除标准
- •Any history of significant cardiac, renal, neurologic, metabolic, pulmonary, gastrointestinal, hematologic abnormality, chronic hepatic disease or any other disease which in the judgment of the investigator would interfere with the study or confound the results.
- •Subject with positive HIV serology or positive HBsAg at screening.
- •History or evidence of any active liver disease.
- •Female subject who are breastfeeding or have a positive pregnancy test at screening or at any time during the study.
- •Inability to give written informed consent
- •History of alcohol or drug abuse within 6 months of screening.
- •Subject who have a positive urine drug screen for substances of abuse (benzodiazepine, THC, opiates, amphetamines, cocaine) at the screening.
- •Mental disorders.
- •Subject with poor venous access
- •Significant swallowing disorders
- •Digestive disorders;
- •Small bowel surgery;
- •Mall absorption disorders.
研究组 & 干预措施
Oshadi D
Experimental
2 dose levels of Oshadi D in 2 food regimen will be administered as following:
- Subjects will receive placebo on the morning of day 1 during fast. Late breakfast will be provided 4 hours following placebo administration.
- On day 8 a single dose of 180mg Oshadi D will be administrated during fast. Late breakfast will be provided 4 hours following drug administration
- On day 16 subjects will be administered with 360mg of Oshadi D during fast. Late breakfast will be provided 4 hours following drug administration.
- On day 24, 180mg of Oshadi D will be administrated immediately after breakfast.
- On day 32, subject will be administered with 360mg of Oshadi immediately after breakfast.
干预措施: Oshadi D (Drug)
结局指标
主要结局
DNase activity level (Kunitz/mL) for 2 dose levels, and different food regimen
时间窗: 24 hours
次要结局
- Maximum plasma DNase concentration (ng/mL) in different food regimen and dose levels(24 hours)
研究者
研究点 (1)
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