NCT02800824已完成1 期
Bioequivalence Study of Budesonide Rectal Aerosol Foam and Uceris® Rectal Aerosol Foam
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Padagis LLC
- 主要终点
- AUC from time 0 extrapolated to infinity (AUC0-∞)
研究概览
简要总结
To evaluate the bioequivalence between the Test Product Budesonide rectal aerosol foam and Reference Product Uceris® rectal aerosol foam after a single-dose in healthy subjects
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy, non-smoking, male and female subjects, 18 years of age or over.
- •No clinically significant findings in vital signs measurements or 12-lead electrocardiogram (ECG) or abnormal laboratory values.
- •Have no significant diseases.
- •Willing to use an acceptable, effective method of contraception.
- •Informed on the nature of the study and have agreed to and are able to read, review and sign all consent documents.
- •Have no clinically significant findings from a physical examination.
排除标准
- •Known history or presence of clinically significant neurologic, hematologic, endocrine, oncologic, pulmonary, immunologic, genitourinary, psychiatric, or cardiovascular disease or any other condition which, in the opinion of the Investigator, would jeopardize the safety of the subject or impact the validity of the study results
- •Known history or presence of hypersensitivity or idiosyncratic reaction to budesonide, any other components of the drug products, or any other drug substances with similar activity or sodium phosphate
- •History or presence or of diabetes mellitus, glaucoma or cataracts, hypertension, or osteoporosis
- •History of drug or alcohol addiction requiring treatment.
- •History of malabsorption within the last year.
- •Presence of hepatic or renal dysfunction.
- •Presence of a medical condition requiring regular medication (prescription and/or over-the-counter) with systemic absorption.
- •Positive test result for HIV, Hepatitis B surface antigen, or Hepatitis C antibody.
研究组 & 干预措施
Budesonide rectal foam
Experimental
干预措施: Budesonide (Drug)
Uceris rectal foam
Active Comparator
干预措施: Uceris (Drug)
结局指标
主要结局
AUC from time 0 extrapolated to infinity (AUC0-∞)
时间窗: 24 hours
Maximum observed plasma drug concentration (Cmax)
时间窗: 24 hours
AUC from time 0 to 24 hours (AUC0-24)
时间窗: 24 hours
次要结局
未报告次要终点
研究者
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