A Phase I, Open-label, Randomised, 3-way Crossover Study to Demonstrate Bioequivalence of a Single Oral Dose of Naproxen Administered as VIMOVO Manufactured at AstraZeneca AB Compared to That of VIMOVO Manufactured by Patheon Pharmaceuticals and a Marketed Enteric-coated Naproxen Formulation (Manufactured by Roche) in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Change in area under the plasma concentration-time curve (AUC) from time zero to infinity
研究概览
简要总结
The primary purpose is to demonstrate the bioequivalence of naproxen administered as VIMOVO manufactured at a new facility in Sweden (AstraZeneca) to that of naproxen administered as VIMOVO manufactured in the USA (Patheon) and to a marketed enteric-coated naproxen formulation.
详细描述
A Phase I, Open-label, Randomised, 3-way Crossover Study to demonstrate Bioequivalence of a Single Oral Dose of Naproxen administered as VIMOVO manufactured at AstraZeneca AB compared to that of VIMOVO manufactured by Patheon Pharmaceuticals and a marketed enteric-coated Naproxen Formulation (Manufactured by Roche) in Healthy Volunteers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 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
- •Healthy male or female volunteer, aged 18 - 55 years (inclusive)
- •Female volunteers must be non-pregnant and non-lactating and have a negative urine pregnancy test result prior to enrolment into the study.
- •Female volunteers of childbearing potential must be using appropriate birth control during the entire duration of the study
- •Body mass index of = 19 to =30 kg/m2 (inclusive) and weights of = 50 to = 100 kg (inclusive)
排除标准
- •Volunteer who is likely to have unrecognized cardiovascular or cerebrovascular disease, based on history or risk factors, or who has a clinical significant ECG finding at screening
- •Uncontrolled hypertension defined as resting systolic pressure >140 mmHg or diastolic pressure >90 mmHg at screening or admission to Period 1
- •Presence or prior history of abnormal bleeding or bleeding disorders, or any volunteer with significant history of peptic ulcer disease or other acid related gastrointestinal symptoms
- •Any gastrointestinal disease, abnormality or gastric surgery that may interfere with gastric emptying, motility and drug absorption
研究组 & 干预措施
1
Treatment order : A, B, C
干预措施: VIMOVO (AstraZeneca) (Drug)
1
Treatment order : A, B, C
干预措施: VIMOVO (Patheon) (Drug)
1
Treatment order : A, B, C
干预措施: Marketed enteric-coated naproxen formulation (Drug)
2
Treatment order : B, C, A
干预措施: VIMOVO (AstraZeneca) (Drug)
2
Treatment order : B, C, A
干预措施: VIMOVO (Patheon) (Drug)
2
Treatment order : B, C, A
干预措施: Marketed enteric-coated naproxen formulation (Drug)
3
Treatment order : C, A, B
干预措施: VIMOVO (AstraZeneca) (Drug)
3
Treatment order : C, A, B
干预措施: VIMOVO (Patheon) (Drug)
3
Treatment order : C, A, B
干预措施: Marketed enteric-coated naproxen formulation (Drug)
4
Treatment order : A, C, B
干预措施: VIMOVO (AstraZeneca) (Drug)
4
Treatment order : A, C, B
干预措施: VIMOVO (Patheon) (Drug)
4
Treatment order : A, C, B
干预措施: Marketed enteric-coated naproxen formulation (Drug)
5
Treatment order : B, A, C
干预措施: VIMOVO (AstraZeneca) (Drug)
5
Treatment order : B, A, C
干预措施: VIMOVO (Patheon) (Drug)
5
Treatment order : B, A, C
干预措施: Marketed enteric-coated naproxen formulation (Drug)
6
Treatment order : C, B, A
干预措施: VIMOVO (AstraZeneca) (Drug)
6
Treatment order : C, B, A
干预措施: VIMOVO (Patheon) (Drug)
6
Treatment order : C, B, A
干预措施: Marketed enteric-coated naproxen formulation (Drug)
结局指标
主要结局
Change in area under the plasma concentration-time curve (AUC) from time zero to infinity
时间窗: Pre-dose to Day 4
次要结局
- Number of subjects with Adverse Events as a measure of Safety and Tolerability(Day 4)