NCT01550926已完成1 期
A Study to Assess the Pharmacologic Equivalence of Two Orlistat Dosage Forms
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Fecal fat excretion
研究概览
简要总结
The purpose of this study is to determine whether a new dosage form and dose of orlistat is equivalent to the currently marketed form.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •age: 18-60 years
- •Body Mass Index: 25-33
排除标准
- •gastrointestinal disease
- •organ transplant
- •HIV, hepatitis B or C
- •food allergies
- •alcohol or other substance abuse
研究组 & 干预措施
Arm 1
Active Comparator
60 mg orlistat
干预措施: 60 mg orlistat (Drug)
Arm 2
Active Comparator
120 mg orlistat (2 X 60 mg capsules)
干预措施: 120 mg orlistat (Drug)
Arm 3
Experimental
orlistat experimental formulation
干预措施: orlistat experimental dose (Drug)
结局指标
主要结局
Fecal fat excretion
时间窗: 9 days
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
A Research Study Looking at the Comparability of 2 Different Forms of Oral Semaglutide in Healthy PeopleHealthy VolunteersType 2 DiabetesNCT05227196Novo Nordisk A/S546
已完成
1 期
A Study To Determine If Two Different Versions Of Topotecan Have The Same Potency In Patients With Advanced Solid TumorsLung Cancer, Small CellNCT00259935GlaxoSmithKline107
已完成
不适用
Bioequivalence Study on Vitamin D in Healthy AdultsMeasure Absorption of Vitamin D in BloodNCT03552653Church & Dwight Company, Inc.31
已完成
1 期
Bioequivalence of a Fixed Dose Combination Tablet Linagliptin/Pioglitazone Compared With Its Mono-componentsHealthyNCT01276327Boehringer Ingelheim64
已完成
1 期
A Clinical Trial to Compare and Evaluate the Pharmacokinetic Characteristics and the Safety of Fimasartan in Renal Impairment Patients and Healthy VolunteersRenal ImpairmentNCT01148368Boryung Pharmaceutical Co., Ltd16